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TÜV NORD CERT GmbHLangemarckstraße 2045141 ESSENGermany
0044 *MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
- *MD 1302 - Monitoring devices of vital physiological
parameters
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
- *MD 1402 - Devices utilising non-ionizing radiation
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
- *MD 0101 - Non-active devices for anaesthesia,
emergency and intensive care
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
- *MD 0104 - Non-active medical devices with
measuring function
- *MD 0105 - Non-active ophthalmologic devices
- *MD 0106 - Non-active instruments
- *MD 0107 - Contraceptive medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
- *MD 0109 - Non-active devices for in vitro fertilisation
(IVF) and assisted reproductive technologies (ART)
*MD 0200 - Non-active implants
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
1 / 301
- *MD 0201 - Non-active cardiovascular implants
- *MD 0202 - Non-active orthopaedic implants
- *MD 0203 - Non-active functional implants
- *MD 0204 - Non-active soft tissue implants
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
- *MD 0302 - Suture material and clamps
- *MD 0303 - Other medical devices for wound care
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
- *MD 0402 - Dental materials
- *MD 0403 - Dental implants
*MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
- *MD 1103 - Devices for stimulation or inhibition
- *MD 1104 - Active surgical devices
- *MD 1105 - Active ophthalmologic devices
- *MD 1106 - Active dental devices
- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1108 - Active rehabilitation devices and active
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
2 / 301
prostheses
- *MD 1109 - Active devices for patient positioning and
transport
*MD 1100 - General active medical devices
- *MD 1111 - Software
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
without medical devices according
to Commission Regulation (EU) No
722/2012
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
for active medical devices only
*MDS 7006 - Medical devices in sterile condition
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbedNational Standards Authority of Ireland (NSAI) 0050 *MD 0100 - General non-active, non-implantable EC declaration of Annex II
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
3 / 301
1 Swift Square, Northwood, SantryDublin 9Ireland
medical devices
- *MD 0101 - Non-active devices for anaesthesia,
emergency and intensive care
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
- *MD 0104 - Non-active medical devices with
measuring function
- *MD 0105 - Non-active ophthalmologic devices
- *MD 0106 - Non-active instruments
- *MD 0107 - Contraceptive medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
- *MD 0109 - Non-active devices for in vitro fertilisation
(IVF) and assisted reproductive technologies (ART)
*MD 0200 - Non-active implants
- *MD 0201 - Non-active cardiovascular implants
- *MD 0202 - Non-active orthopaedic implants
- *MD 0203 - Non-active functional implants
- *MD 0204 - Non-active soft tissue implants
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
- *MD 0302 - Suture material and clamps
- *MD 0303 - Other medical devices for wound care
*MD 0400 - Non-active dental devices and accessories
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
4 / 301
- *MD 0401 - Non-active dental equipment and
instruments
- *MD 0402 - Dental materials
- *MD 0403 - Dental implants
*MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
- *MD 1103 - Devices for stimulation or inhibition
- *MD 1104 - Active surgical devices
- *MD 1105 - Active ophthalmologic devices
- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1109 - Active devices for patient positioning and
transport
- *MD 1111 - Software
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
- *MD 1302 - Monitoring devices of vital physiological
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
5 / 301
parameters
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1402 - Devices utilising non-ionizing radiation
- *MD 1403 - Devices for hyperthermia / hypothermia
- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
*MDS 7003 - Medical devices incorporating derivates of
human blood, according to Directive 2000/70/EC,
amended by Directive 2001/104/EC
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition
*MDS 7007 - Medical devices utilising micromechanics
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbedIMQ ISTITUTO ITALIANO DEL MARCHIO DIQUALITÀ S.P.A.Via Quintiliano, 4320138 - MILANOItaly
0051 *MD 0100 - General non-active, non-implantable
medical devices
- *MD 0101 - Non-active devices for anaesthesia,
emergency and intensive care
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
Annex II
Annex V
Annex VI
exclusion medical devices class III
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
6 / 301
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
exclusion medical devices class III
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
exclusion medical devices class III
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0104 - Non-active medical devices with
measuring function
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
Annex II
Annex V
Annex VI
exclusion medical devices class III
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
7 / 301
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0105 - Non-active ophthalmologic devices
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
exclusion medical devices class III
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0106 - Non-active instruments
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
exclusion medical devices class III
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0107 - Contraceptive medical devices
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
Annex II
Annex V
Annex VI
exclusion medical devices class III
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
8 / 301
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
exclusion medical devices class III
*MD 0200 - Non-active implants
- *MD 0202 - Non-active orthopaedic implants
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
exclusion medical devices class III
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
Annex II
Annex V
Annex VI
exclusion medical devices class III
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
9 / 301
assurance)
*MD 0300 - Devices for wound care
- *MD 0302 - Suture material and clamps
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
exclusion medical devices class III
*MD 0300 - Devices for wound care
- *MD 0303 - Other medical devices for wound care
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
exclusion medical devices class III
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
exclusion medical devices class III
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
10 / 301
*MD 0400 - Non-active dental devices and accessories
- *MD 0402 - Dental materials
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
exclusion medical devices class III
*MD 0400 - Non-active dental devices and accessories
- *MD 0403 - Dental implants
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
exclusion medical devices class III
*MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
Annex III
Annex IV
Annex II
Annex V
Annex VI
exclusion medical devices class III
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
11 / 301
assurance)
*MD 1100 - General active medical devices
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
exclusion medical devices class III
- hyperbaric chambers only annex
II - V - VI
*MD 1100 - General active medical devices
- *MD 1103 - Devices for stimulation or inhibition
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
exclusion medical devices class III
*MD 1100 - General active medical devices
- *MD 1104 - Active surgical devices
EC type-examination
EC verification
EC declaration of
conformity (full quality
Annex III
Annex IV
Annex II
Annex V
exclusion medical devices class III
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
12 / 301
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex VI
*MD 1100 - General active medical devices
- *MD 1105 - Active ophthalmologic devices
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
exclusion medical devices class III
*MD 1100 - General active medical devices
- *MD 1106 - Active dental devices
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
Annex III
Annex IV
Annex II
Annex V
Annex VI
exclusion medical devices class III
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
13 / 301
assurance)
*MD 1100 - General active medical devices
- *MD 1107 - Active devices for disinfection and
sterilisation
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
exclusion medical devices class III
*MD 1100 - General active medical devices
- *MD 1108 - Active rehabilitation devices and active
prostheses
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
exclusion medical devices class III
*MD 1100 - General active medical devices
- *MD 1109 - Active devices for patient positioning and
transport
EC type-examination
EC verification
EC declaration of
conformity (full quality
Annex III
Annex IV
Annex II
Annex V
exclusion medical devices class III
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
14 / 301
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex VI
*MD 1100 - General active medical devices
- *MD 1111 - Software
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
exclusion medical devices class III
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
exclusion medical devices class III
*MD 1200 - Devices for imaging EC type-examination Annex III exclusion medical devices class III
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
15 / 301
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex IV
Annex II
Annex V
Annex VI
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
exclusion medical devices class III
*MD 1300 - Monitoring devices
- *MD 1302 - Monitoring devices of vital physiological
parameters
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
Annex III
Annex IV
Annex II
Annex V
Annex VI
exclusion medical devices class III
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
16 / 301
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
exclusion medical devices class III
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1402 - Devices utilising non-ionizing radiation
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
exclusion medical devices class III
*MD 1400 - Devices for radiation therapy and thermo
therapy
EC type-examination Annex III exclusion medical devices class III-
exclusion devices for hypothermia
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
17 / 301
- *MD 1403 - Devices for hyperthermia / hypothermia EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex IV
Annex II
Annex V
Annex VI
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
exclusion medical devices class III
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
exclusion medical devices class III
*MDS 7005 - Medical devices referencing the Directive
89/686/EEC on personal protective equipment (PPE)
exclusion medical devices class III
*MDS 7006 - Medical devices in sterile condition exclusion medical devices class IIIIRCM ISTITUTO DI RICERCHE E COLLAUDIMASINI S.R.L.
0068 *MD 0100 - General non-active, non-implantable
medical devices
EC type-examination Annex III Except class III Medical Devices
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
18 / 301
Via Moscova, 1120017 - Rho (MI)Italy
- *MD 0101 - Non-active devices for anaesthesia,
emergency and intensive care
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex IV
Annex II
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Except class III Medical Devices
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0104 - Non-active medical devices with
measuring function
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
Annex III
Annex IV
Annex II
Annex V
Annex VI
Except class III Medical Devices
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
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quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0105 - Non-active ophthalmologic devices
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Except class III Medical Devices
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0106 - Non-active instruments
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Except class III Medical Devices
*MD 0100 - General non-active, non-implantable
medical devices
EC type-examination Annex III Except class III Medical Devices
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
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- *MD 0107 - Contraceptive medical devices EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex IV
Annex II
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Except class III Medical Devices
*MD 0200 - Non-active implants
- *MD 0202 - Non-active orthopaedic implants
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Except class III Medical Devices
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
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*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Except class III Medical Devices
*MD 0300 - Devices for wound care
- *MD 0302 - Suture material and clamps
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Except class III Medical Devices
Except suture material
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Except class III Medical Devices
*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Except class III Medical Devices
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
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- *MD 0402 - Dental materials conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex V
Annex VI
*MD 0400 - Non-active dental devices and accessories
- *MD 0403 - Dental implants
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Except class III Medical Devices
*MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Except class III Medical Devices
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
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*MD 1100 - General active medical devices
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Except class III Medical Devices
Except hyperbaric chambers
*MD 1100 - General active medical devices
- *MD 1103 - Devices for stimulation or inhibition
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Except class III Medical Devices
*MD 1100 - General active medical devices
- *MD 1104 - Active surgical devices
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Except class III Medical Devices
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
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EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices
- *MD 1105 - Active ophthalmologic devices
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Except class III Medical Devices
*MD 1100 - General active medical devices
- *MD 1106 - Active dental devices
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Except class III Medical Devices
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
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*MD 1100 - General active medical devices
- *MD 1107 - Active devices for disinfection and
sterilisation
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Except class III Medical Devices
*MD 1100 - General active medical devices
- *MD 1108 - Active rehabilitation devices and active
prostheses
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Except class III Medical Devices
Except active prostheses
*MD 1100 - General active medical devices
- *MD 1111 - Software
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
Annex II
Annex V
Annex VI
Except class III Medical Devices
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
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assurance)
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Except class III Medical Devices
*MD 1200 - Devices for imaging
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Except class III Medical Devices
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
EC type-examination
EC verification
EC declaration of
conformity (full quality
Annex III
Annex IV
Annex II
Annex V
Except class III Medical Devices
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
27 / 301
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex VI
*MD 1300 - Monitoring devices
- *MD 1302 - Monitoring devices of vital physiological
parameters
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Except class III Medical Devices
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
Annex III
Annex IV
Annex II
Annex V
Annex VI
Except class III Medical Devices
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
28 / 301
assurance)
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1402 - Devices utilising non-ionizing radiation
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Except class III Medical Devices
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1403 - Devices for hyperthermia / hypothermia
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Except class III Medical Devices
Except Devices for hypothermia
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
Except class III Medical Devices
*MDS 7005 - Medical devices referencing the Directive
89/686/EEC on personal protective equipment (PPE)
Except class III Medical Devices
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
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*MDS 7006 - Medical devices in sterile condition Except class III Medical DevicesBSIKitemark Court Davy Avenue KnowhillMilton Keynes MK5 8PPUnited Kingdom
0086 *MD 0100 - General non-active, non-implantable
medical devices
- *MD 0101 - Non-active devices for anaesthesia,
emergency and intensive care
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
- *MD 0104 - Non-active medical devices with
measuring function
- *MD 0105 - Non-active ophthalmologic devices
- *MD 0106 - Non-active instruments
- *MD 0107 - Contraceptive medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
- *MD 0109 - Non-active devices for in vitro fertilisation
(IVF) and assisted reproductive technologies (ART)
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0110 - Non-active medical devices for ingestion
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
Annex III
Annex IV
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
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conformity (product quality
assurance)
*MD 0200 - Non-active implants
- *MD 0201 - Non-active cardiovascular implants
- *MD 0202 - Non-active orthopaedic implants
- *MD 0203 - Non-active functional implants
- *MD 0204 - Non-active soft tissue implants
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
- *MD 0302 - Suture material and clamps
- *MD 0303 - Other medical devices for wound care
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
- *MD 0402 - Dental materials
- *MD 0403 - Dental implants
*MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
- *MD 1103 - Devices for stimulation or inhibition
- *MD 1104 - Active surgical devices
- *MD 1105 - Active ophthalmologic devices
- *MD 1106 - Active dental devices
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
31 / 301
- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1108 - Active rehabilitation devices and active
prostheses
- *MD 1109 - Active devices for patient positioning and
transport
- *MD 1110 - Active devices for in vitro fertilisation
(IVF) and assisted reproductive therapy (ART)
- *MD 1111 - Software
*MD 1100 - General active medical devices
- *MD 1112 - Medical gas supply systems and parts
thereof
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
32 / 301
physiological parameters
- *MD 1302 - Monitoring devices of vital physiological
parameters
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
- *MD 1402 - Devices utilising non-ionizing radiation
- *MD 1403 - Devices for hyperthermia / hypothermia
- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
*MDS 7003 - Medical devices incorporating derivates of
human blood, according to Directive 2000/70/EC,
amended by Directive 2001/104/EC
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition
*MDS 7008 - Medical devices utilising nanomaterials
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
33 / 301
LLOYD'S REGISTER QUALITY ASSURANCELTD (0088)Hiramford Middlemarch Office Village SiskinDriveCoventry CV3 4FJUnited Kingdom
0088 *MD 0100 - General non-active, non-implantable
medical devices
- *MD 0101 - Non-active devices for anaesthesia,
emergency and intensive care
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
- *MD 0104 - Non-active medical devices with
measuring function
- *MD 0105 - Non-active ophthalmologic devices
- *MD 0106 - Non-active instruments
- *MD 0107 - Contraceptive medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
- *MD 0109 - Non-active devices for in vitro fertilisation
(IVF) and assisted reproductive technologies (ART)
*MD 0200 - Non-active implants
- *MD 0201 - Non-active cardiovascular implants
- *MD 0202 - Non-active orthopaedic implants
- *MD 0203 - Non-active functional implants
- *MD 0204 - Non-active soft tissue implants
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
- *MD 0302 - Suture material and clamps
- *MD 0303 - Other medical devices for wound care
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
34 / 301
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
- *MD 0402 - Dental materials
- *MD 0403 - Dental implants
*MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
- *MD 1103 - Devices for stimulation or inhibition
- *MD 1104 - Active surgical devices
- *MD 1105 - Active ophthalmologic devices
- *MD 1106 - Active dental devices
- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1108 - Active rehabilitation devices and active
prostheses
- *MD 1109 - Active devices for patient positioning and
transport
- *MD 1110 - Active devices for in vitro fertilisation
(IVF) and assisted reproductive therapy (ART)
- *MD 1111 - Software
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
35 / 301
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
- *MD 1302 - Monitoring devices of vital physiological
parameters
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
- *MD 1402 - Devices utilising non-ionizing radiation
- *MD 1403 - Devices for hyperthermia / hypothermia
- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
*MDS 7005 - Medical devices referencing the Directive
89/686/EEC on personal protective equipment (PPE)
*MDS 7006 - Medical devices in sterile condition
*MDS 7007 - Medical devices utilising micromechanics
*MDS 7008 - Medical devices utilising nanomaterials
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
36 / 301
SGS United Kingdom LimitedUnit 202B, Worle Parkway,Weston-super-Mare, Somerset, BS22 6WAUnited Kingdom
0120 *MD 0100 - General non-active, non-implantable
medical devices
- *MD 0101 - Non-active devices for anaesthesia,
emergency and intensive care
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0104 - Non-active medical devices with
measuring function
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0105 - Non-active ophthalmologic devices
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
Full quality assurance
system
Annex II
Annex V
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
37 / 301
- *MD 0106 - Non-active instruments Production quality
assurance
Product quality assurance
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0107 - Contraceptive medical devices
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
Annex III - condoms (with and
without spermicide) Annex IV -
condoms (with and without
spermicide)
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0109 - Non-active devices for in vitro fertilisation
(IVF) and assisted reproductive technologies (ART)
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0200 - Non-active implants
- *MD 0201 - Non-active cardiovascular implants
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0200 - Non-active implants
- *MD 0202 - Non-active orthopaedic implants
Full quality assurance
system
Annex II
Annex V
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
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Production quality
assurance
Product quality assurance
Annex VI
*MD 0200 - Non-active implants
- *MD 0203 - Non-active functional implants
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0200 - Non-active implants
- *MD 0204 - Non-active soft tissue implants
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0300 - Devices for wound care
- *MD 0302 - Suture material and clamps
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0300 - Devices for wound care
- *MD 0303 - Other medical devices for wound care
Full quality assurance
system
Production quality
assurance
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
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Product quality assurance
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0400 - Non-active dental devices and accessories
- *MD 0402 - Dental materials
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0400 - Non-active dental devices and accessories
- *MD 0403 - Dental implants
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
Full quality assurance
system
EC type-examination
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex V
Annex VI
Annex III - Infusion pumps Annex
III - Dialysis equipment
*MD 1100 - General active medical devices
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
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*MD 1100 - General active medical devices
- *MD 1103 - Devices for stimulation or inhibition
Full quality assurance
system
EC type-examination
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex V
Annex VI
Annex III - Defibrillators (External)
*MD 1100 - General active medical devices
- *MD 1104 - Active surgical devices
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1105 - Active ophthalmologic devices
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1106 - Active dental devices
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1107 - Active devices for disinfection and
sterilisation
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1100 - General active medical devices Full quality assurance Annex II
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
41 / 301
- *MD 1108 - Active rehabilitation devices and active
prostheses
system
Production quality
assurance
Product quality assurance
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1109 - Active devices for patient positioning and
transport
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1110 - Active devices for in vitro fertilisation
(IVF) and assisted reproductive therapy (ART)
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1111 - Software
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1200 - Devices for imaging
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
Full quality assurance
system
Production quality
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
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assurance
Product quality assurance
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
Full quality assurance
system
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex IV
Annex V
Annex VI
Annex IV - Clinical Thermometers
Annex IV - Active Medical Devices
(Class I Measuring and IIa only)
*MD 1300 - Monitoring devices
- *MD 1302 - Monitoring devices of vital physiological
parameters
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
Annex III - ECG Monitors Annex IV
- Active Medical Devices (Class I
Measuring and IIa only)
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1402 - Devices utilising non-ionizing radiation
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1400 - Devices for radiation therapy and thermo
therapy
Full quality assurance
system
Annex II
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
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- *MD 1403 - Devices for hyperthermia / hypothermia Production quality
assurance
Product quality assurance
Annex V
Annex VI
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
*MDS 7005 - Medical devices referencing the Directive
89/686/EEC on personal protective equipment (PPE)
*MDS 7006 - Medical devices in sterile condition
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbedTÜV SÜD Product Service GmbHZertifizierstellenRidlerstraße 6580339 MÜNCHENGermany
0123 *MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
- *MD 0302 - Suture material and clamps
- *MD 0303 - Other medical devices for wound care
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
- *MD 0402 - Dental materials
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
44 / 301
- *MD 0403 - Dental implants
*MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
- *MD 1103 - Devices for stimulation or inhibition
- *MD 1104 - Active surgical devices
- *MD 1105 - Active ophthalmologic devices
- *MD 1106 - Active dental devices
- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1108 - Active rehabilitation devices and active
prostheses
- *MD 1109 - Active devices for patient positioning and
transport
- *MD 1111 - Software
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
- *MD 1302 - Monitoring devices of vital physiological
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
45 / 301
parameters
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
- *MD 1402 - Devices utilising non-ionizing radiation
- *MD 1403 - Devices for hyperthermia / hypothermia
- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0101 - Non-active devices for anaesthesia,
emergency and intensive care
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
- *MD 0104 - Non-active medical devices with
measuring function
- *MD 0105 - Non-active ophthalmologic devices
- *MD 0106 - Non-active instruments
- *MD 0107 - Contraceptive medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
Full quality assurance
system
Annex II
Annex III
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
46 / 301
- *MD 0109 - Non-active devices for in vitro fertilisation
(IVF) and assisted reproductive technologies (ART)
*MD 0200 - Non-active implants
- *MD 0201 - Non-active cardiovascular implants
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex IV
Annex V
Annex VI
*MD 0200 - Non-active implants
- *MD 0202 - Non-active orthopaedic implants
- *MD 0203 - Non-active functional implants
- *MD 0204 - Non-active soft tissue implants
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1110 - Active devices for in vitro fertilisation
(IVF) and assisted reproductive therapy (ART)
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
*MDS 7003 - Medical devices incorporating derivates of
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
47 / 301
human blood, according to Directive 2000/70/EC,
amended by Directive 2001/104/EC
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
for active medical devices only
*MDS 7006 - Medical devices in sterile condition
*MDS 7007 - Medical devices utilising micromechanics
*MDS 7008 - Medical devices utilising nanomaterials
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbedDEKRA Certification GmbHHandwerkstraße 1570565 STUTTGARTGermany
0124 *MD 0100 - General non-active, non-implantable
medical devices
- *MD 0101 - Non-active devices for anaesthesia,
emergency and intensive care
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
Full quality assurance
system
Annex II
Annex V
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
48 / 301
- *MD 0104 - Non-active medical devices with
measuring function
Production quality
assurance
Product quality assurance
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0105 - Non-active ophthalmologic devices
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0106 - Non-active instruments
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0107 - Contraceptive medical devices
Full quality assurance
system
EC type-examination
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex V
Annex VI
Annex III for condoms only
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0109 - Non-active devices for in vitro fertilisation
Full quality assurance
system
Production quality
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
49 / 301
(IVF) and assisted reproductive technologies (ART) assurance
Product quality assurance
*MD 0200 - Non-active implants
- *MD 0201 - Non-active cardiovascular implants
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0200 - Non-active implants
- *MD 0202 - Non-active orthopaedic implants
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0200 - Non-active implants
- *MD 0203 - Non-active functional implants
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0200 - Non-active implants
- *MD 0204 - Non-active soft tissue implants
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
50 / 301
*MD 0300 - Devices for wound care
- *MD 0302 - Suture material and clamps
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0300 - Devices for wound care
- *MD 0303 - Other medical devices for wound care
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0400 - Non-active dental devices and accessories
- *MD 0402 - Dental materials
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0400 - Non-active dental devices and accessories
- *MD 0403 - Dental implants
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
Full quality assurance
system
Annex II
Annex III
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
51 / 301
infusion and haemopheresis EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex IV
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1103 - Devices for stimulation or inhibition
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1104 - Active surgical devices
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1105 - Active ophthalmologic devices
Full quality assurance
system
Annex II
Annex V
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
52 / 301
Production quality
assurance
Product quality assurance
Annex VI
*MD 1100 - General active medical devices
- *MD 1106 - Active dental devices
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1107 - Active devices for disinfection and
sterilisation
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1108 - Active rehabilitation devices and active
prostheses
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1109 - Active devices for patient positioning and
transport
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
53 / 301
*MD 1100 - General active medical devices
- *MD 1111 - Software
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
*MD 1200 - Devices for imaging
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
Full quality assurance
system
EC type-examination
EC verification
Production quality
Annex II
Annex III
Annex IV
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
54 / 301
assurance
Product quality assurance
*MD 1300 - Monitoring devices
- *MD 1302 - Monitoring devices of vital physiological
parameters
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1402 - Devices utilising non-ionizing radiation
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1403 - Devices for hyperthermia / hypothermia
Full quality assurance
system
EC type-examination
EC verification
Production quality
Annex II
Annex III
Annex IV
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
55 / 301
assurance
Product quality assurance
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
for active medical devices only
*MDS 7006 - Medical devices in sterile condition
*MDS 7007 - Medical devices utilising micromechanics
*MDS 7008 - Medical devices utilising nanomaterials
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbedTÜV Rheinland LGA Products GmbHTillystraße 290431 NürnbergGermany
0197 *MD 0200 - Non-active implants
- *MD 0201 - Non-active cardiovascular implants
Full quality assurance
system
EC type-examination
EC verification
Annex II
Annex III
Annex IV
Annex V
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
56 / 301
Production quality
assurance
Product quality assurance
Annex VI
*MD 0200 - Non-active implants
- *MD 0202 - Non-active orthopaedic implants
- *MD 0203 - Non-active functional implants
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0200 - Non-active implants
- *MD 0204 - Non-active soft tissue implants
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0300 - Devices for wound care
- *MD 0302 - Suture material and clamps
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
57 / 301
*MD 0300 - Devices for wound care
- *MD 0303 - Other medical devices for wound care
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
*MD 0400 - Non-active dental devices and accessories
- *MD 0402 - Dental materials
- *MD 0403 - Dental implants
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1109 - Active devices for patient positioning and
transport
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
- *MD 1103 - Devices for stimulation or inhibition
- *MD 1104 - Active surgical devices
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
58 / 301
- *MD 1105 - Active ophthalmologic devices
- *MD 1106 - Active dental devices
- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1108 - Active rehabilitation devices and active
prostheses
- *MD 1110 - Active devices for in vitro fertilisation
(IVF) and assisted reproductive therapy (ART)
- *MD 1111 - Software
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0104 - Non-active medical devices with
measuring function
- *MD 0105 - Non-active ophthalmologic devices
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0106 - Non-active instruments
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
59 / 301
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0107 - Contraceptive medical devices
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
- *MD 0109 - Non-active devices for in vitro fertilisation
(IVF) and assisted reproductive technologies (ART)
- *MD 0101 - Non-active devices for anaesthesia,
emergency and intensive care
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
- *MD 1302 - Monitoring devices of vital physiological
parameters
*MD 1400 - Devices for radiation therapy and thermo
therapy
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
60 / 301
- *MD 1401 - Devices utilising ionizing radiation
- *MD 1402 - Devices utilising non-ionizing radiation
- *MD 1403 - Devices for hyperthermia / hypothermia
- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
for active medical devices only
*MDS 7006 - Medical devices in sterile condition
*MDS 7007 - Medical devices utilising micromechanics
*MDS 7008 - Medical devices utilising nanomaterials
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbedDQS Medizinprodukte GmbHAugust-Schanz-Straße 2160433 FRANKFURT AM MAINGermany
0297 *MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1200 - Devices for imaging
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
Full quality assurance
system
Production quality
assurance
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
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Product quality assurance
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1300 - Monitoring devices
- *MD 1302 - Monitoring devices of vital physiological
parameters
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1402 - Devices utilising non-ionizing radiation
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
62 / 301
medical devices
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
system
Production quality
assurance
Annex V
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0101 - Non-active devices for anaesthesia,
emergency and intensive care
Full quality assurance
system
Production quality
assurance
Annex II
Annex V
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
Full quality assurance
system
Production quality
assurance
Annex II
Annex V
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0104 - Non-active medical devices with
measuring function
Full quality assurance
system
Production quality
assurance
Annex II
Annex V
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0105 - Non-active ophthalmologic devices
Full quality assurance
system
Production quality
assurance
Annex II
Annex V
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0106 - Non-active instruments
Full quality assurance
system
Production quality
assurance
Annex II
Annex V
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0107 - Contraceptive medical devices
Full quality assurance
system
Production quality
assurance
Annex II
Annex V
condoms only
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
63 / 301
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
Full quality assurance
system
Production quality
assurance
Annex II
Annex V
*MD 0200 - Non-active implants
- *MD 0201 - Non-active cardiovascular implants
Full quality assurance
system
Production quality
assurance
Annex II
Annex V
vascular implants only
*MD 0200 - Non-active implants
- *MD 0202 - Non-active orthopaedic implants
Full quality assurance
system
Production quality
assurance
Annex II
Annex V
*MD 0200 - Non-active implants
- *MD 0203 - Non-active functional implants
Full quality assurance
system
Production quality
assurance
Annex II
Annex V
*MD 0200 - Non-active implants
- *MD 0204 - Non-active soft tissue implants
Full quality assurance
system
Production quality
assurance
Annex II
Annex V
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
Full quality assurance
system
Production quality
assurance
Annex II
Annex V
*MD 0300 - Devices for wound care
- *MD 0302 - Suture material and clamps
Full quality assurance
system
Production quality
Annex II
Annex V
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
64 / 301
assurance
*MD 0300 - Devices for wound care
- *MD 0303 - Other medical devices for wound care
Full quality assurance
system
Production quality
assurance
Annex II
Annex V
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
Full quality assurance
system
Production quality
assurance
Annex II
Annex V
*MD 0400 - Non-active dental devices and accessories
- *MD 0402 - Dental materials
Full quality assurance
system
Production quality
assurance
Annex II
Annex V
*MD 0400 - Non-active dental devices and accessories
- *MD 0403 - Dental implants
Full quality assurance
system
Production quality
assurance
Annex II
Annex V
*MD 1100 - General active medical devices
- *MD 1104 - Active surgical devices
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1105 - Active ophthalmologic devices
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
65 / 301
*MD 1100 - General active medical devices
- *MD 1106 - Active dental devices
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1107 - Active devices for disinfection and
sterilisation
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1108 - Active rehabilitation devices and active
prostheses
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1109 - Active devices for patient positioning and
transport
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1111 - Software
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
Full quality assurance
system
Annex II
Annex V
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
66 / 301
infusion and haemopheresis Production quality
assurance
Product quality assurance
Annex VI
*MD 1100 - General active medical devices
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1103 - Devices for stimulation or inhibition
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
for active medical devices only
*MDS 7006 - Medical devices in sterile condition
*MDS 7007 - Medical devices utilising micromechanics
*MDS 7008 - Medical devices utilising nanomaterials
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbedAGENCIA ESPAÑOLA DE MEDICAMENTOS 0318 *MD 1200 - Devices for imaging EC type-examination Annex III
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
67 / 301
Y PRODUCTOS SANITARIOSCampezo 1. Edificio 828022 MADRIDSpain
- *MD 1201 - Imaging devices utilising ionizing
radiation
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
- *MD 1302 - Monitoring devices of vital physiological
parameters
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
- *MD 1402 - Devices utilising non-ionizing radiation
- *MD 1403 - Devices for hyperthermia / hypothermia
- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
- *MD 0101 - Non-active devices for anaesthesia,
emergency and intensive care
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
- *MD 0104 - Non-active medical devices with
measuring function
- *MD 0105 - Non-active ophthalmologic devices
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex IV
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
68 / 301
- *MD 0106 - Non-active instruments
- *MD 0107 - Contraceptive medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
- *MD 0109 - Non-active devices for in vitro fertilisation
(IVF) and assisted reproductive technologies (ART)
*MD 0200 - Non-active implants
- *MD 0201 - Non-active cardiovascular implants
- *MD 0202 - Non-active orthopaedic implants
- *MD 0203 - Non-active functional implants
- *MD 0204 - Non-active soft tissue implants
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
- *MD 0302 - Suture material and clamps
- *MD 0303 - Other medical devices for wound care
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
- *MD 0402 - Dental materials
- *MD 0403 - Dental implants
*MD 1100 - General active medical devices
- *MD 1104 - Active surgical devices
- *MD 1105 - Active ophthalmologic devices
- *MD 1106 - Active dental devices
- *MD 1107 - Active devices for disinfection and
sterilisation
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
69 / 301
- *MD 1108 - Active rehabilitation devices and active
prostheses
- *MD 1109 - Active devices for patient positioning and
transport
- *MD 1110 - Active devices for in vitro fertilisation
(IVF) and assisted reproductive therapy (ART)
- *MD 1111 - Software
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
- *MD 1103 - Devices for stimulation or inhibition
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7005 - Medical devices referencing the Directive
89/686/EEC on personal protective equipment (PPE)
*MDS 7006 - Medical devices in sterile condition
*MDS 7007 - Medical devices utilising micromechanics
*MDS 7008 - Medical devices utilising nanomaterials
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
70 / 301
absorbedDEKRA Certification B.V.Meander 1051 / P.O. Box 51856825 MJ ARNHEM / 6802 ED ARNHEMNetherlands
0344 *MD 0100 - General non-active, non-implantable
medical devices
- *MD 0101 - Non-active devices for anaesthesia,
emergency and intensive care
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
- *MD 0104 - Non-active medical devices with
measuring function
- *MD 0105 - Non-active ophthalmologic devices
- *MD 0106 - Non-active instruments
- *MD 0107 - Contraceptive medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
- *MD 0109 - Non-active devices for in vitro fertilisation
(IVF) and assisted reproductive technologies (ART)
*MD 0200 - Non-active implants
- *MD 0201 - Non-active cardiovascular implants
- *MD 0202 - Non-active orthopaedic implants
- *MD 0203 - Non-active functional implants
- *MD 0204 - Non-active soft tissue implants
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
- *MD 0302 - Suture material and clamps
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
71 / 301
- *MD 0303 - Other medical devices for wound care
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
- *MD 0402 - Dental materials
- *MD 0403 - Dental implants
*MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
- *MD 1103 - Devices for stimulation or inhibition
- *MD 1104 - Active surgical devices
- *MD 1105 - Active ophthalmologic devices
- *MD 1106 - Active dental devices
- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1108 - Active rehabilitation devices and active
prostheses
- *MD 1109 - Active devices for patient positioning and
transport
- *MD 1110 - Active devices for in vitro fertilisation
(IVF) and assisted reproductive therapy (ART)
- *MD 1111 - Software
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
72 / 301
radiation
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
- *MD 1302 - Monitoring devices of vital physiological
parameters
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
- *MD 1402 - Devices utilising non-ionizing radiation
- *MD 1403 - Devices for hyperthermia / hypothermia
- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
*MDS 7003 - Medical devices incorporating derivates of
human blood, according to Directive 2000/70/EC,
amended by Directive 2001/104/EC
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition
*MDS 7007 - Medical devices utilising micromechanics
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
73 / 301
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by softwareISTITUTO SUPERIORE DI SANITA'Viale Regina Elena, 29900161 - ROMAItaly
0373 All medical devices Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
SP Sveriges Tekniska Forskningsinstitut AB/SP Technical Research Institute of SwedenBox 857501 15 BORASSweden
0402 *MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0104 - Non-active medical devices with
measuring function
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
74 / 301
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0101 - Non-active devices for anaesthesia,
emergency and intensive care
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0106 - Non-active instruments
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0200 - Non-active implants
- *MD 0203 - Non-active functional implants
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
Bone-anchored implants for dental
and cranio-facial reconstruction
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0400 - Non-active dental devices and accessories
- *MD 0403 - Dental implants
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
Bone-anchored implants for dental
and cranio-facial reconstruction
*MD 1100 - General active medical devices
- *MD 1102 - Respiratory devices, devices including
Full quality assurance
system
Annex II
Annex V
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
75 / 301
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
Production quality
assurance
Product quality assurance
Annex VI
*MD 1100 - General active medical devices
- *MD 1106 - Active dental devices
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1111 - Software
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile conditionTÜV AUSTRIA SERVICES GMBHKrugerstrasse 161015 WIENAustria
0408 *MD 0100 - General non-active, non-implantable
medical devices
- *MD 0101 - Non-active devices for anaesthesia,
emergency and intensive care
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
76 / 301
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0104 - Non-active medical devices with
measuring function
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
77 / 301
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0105 - Non-active ophthalmologic devices
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0106 - Non-active instruments
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
78 / 301
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0107 - Contraceptive medical devices
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0109 - Non-active devices for in vitro fertilisation
(IVF) and assisted reproductive technologies (ART)
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
79 / 301
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants
- *MD 0202 - Non-active orthopaedic implants
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
*MD 0200 - Non-active implants
- *MD 0203 - Non-active functional implants
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
neurological and neurosurgical
implants excluded
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
80 / 301
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
*MD 0300 - Devices for wound care
- *MD 0302 - Suture material and clamps
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
*MD 0300 - Devices for wound care
- *MD 0303 - Other medical devices for wound care
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
81 / 301
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
*MD 0400 - Non-active dental devices and accessories
- *MD 0402 - Dental materials
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
82 / 301
*MD 0400 - Non-active dental devices and accessories
- *MD 0403 - Dental implants
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
83 / 301
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices
- *MD 1103 - Devices for stimulation or inhibition
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1104 - Active surgical devices
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
84 / 301
*MD 1100 - General active medical devices
- *MD 1105 - Active ophthalmologic devices
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1106 - Active dental devices
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1107 - Active devices for disinfection and
sterilisation
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
85 / 301
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices
- *MD 1108 - Active rehabilitation devices and active
prostheses
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1109 - Active devices for patient positioning and
transport
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
86 / 301
*MD 1100 - General active medical devices
- *MD 1110 - Active devices for in vitro fertilisation
(IVF) and assisted reproductive therapy (ART)
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1111 - Software
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
87 / 301
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1200 - Devices for imaging
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
88 / 301
*MD 1300 - Monitoring devices
- *MD 1302 - Monitoring devices of vital physiological
parameters
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1402 - Devices utilising non-ionizing radiation
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
89 / 301
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1403 - Devices for hyperthermia / hypothermia
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
90 / 301
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
tissues according directive
2003/32/EC excluded
*MDS 7003 - Medical devices incorporating derivates of
human blood, according to Directive 2000/70/EC,
amended by Directive 2001/104/EC
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition
*MDS 7007 - Medical devices utilising micromechanics
*MDS 7008 - Medical devices utilising nanomaterials
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by softwareINTERTEK SEMKO ABTorshamnsgatan 43 Box 1103SE-164 22 KISTASweden
0413 *MD 0100 - General non-active, non-implantable
medical devices
- *MD 0101 - Non-active devices for anaesthesia,
emergency and intensive care
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
91 / 301
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
- *MD 0104 - Non-active medical devices with
measuring function
- *MD 0105 - Non-active ophthalmologic devices
- *MD 0106 - Non-active instruments
- *MD 0107 - Contraceptive medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
*MD 0200 - Non-active implants
- *MD 0202 - Non-active orthopaedic implants
- *MD 0203 - Non-active functional implants
- *MD 0204 - Non-active soft tissue implants
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
- *MD 0302 - Suture material and clamps
- *MD 0303 - Other medical devices for wound care
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
- *MD 0402 - Dental materials
- *MD 0403 - Dental implants
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
92 / 301
*MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
- *MD 1103 - Devices for stimulation or inhibition
- *MD 1104 - Active surgical devices
- *MD 1105 - Active ophthalmologic devices
- *MD 1106 - Active dental devices
- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1108 - Active rehabilitation devices and active
prostheses
- *MD 1109 - Active devices for patient positioning and
transport
- *MD 1111 - Software
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
- *MD 1302 - Monitoring devices of vital physiological
parameters
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
93 / 301
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
- *MD 1402 - Devices utilising non-ionizing radiation
- *MD 1403 - Devices for hyperthermia / hypothermia
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile conditionITALCERT SRLViale Sarca, 33620126 - MILANOItaly
0426 *MD 0100 - General non-active, non-implantable
medical devices
- *MD 0101 - Non-active devices for anaesthesia,
emergency and intensive care
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
exclusion medical devices class III
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
exclusion medical devices class III,
except surgically devices, intended
for transient use, in direct contact
with central nervous system
*MD 0100 - General non-active, non-implantable
medical devices
EC declaration of
conformity (full quality
Annex II exclusion medical devices class III
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
94 / 301
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0104 - Non-active medical devices with
measuring function
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
exclusion medical devices class III
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0105 - Non-active ophthalmologic devices
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
exclusion medical devices class III
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0106 - Non-active instruments
EC declaration of
conformity (full quality
assurance system)
Annex II
Annex V
Annex VI
exclusion medical devices class III
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
95 / 301
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0107 - Contraceptive medical devices
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
exclusion medical devices class III
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
exclusion medical devices class III
*MD 0200 - Non-active implants
- *MD 0202 - Non-active orthopaedic implants
EC declaration of
conformity (full quality
assurance system)
EC declaration of
Annex II
Annex V
Annex VI
exclusion medical devices class III,
except hip, knee and shoulder joint
replacements and except
orthopaedic implants utilizing
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
96 / 301
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
biological active coatings and/or
materials or being wholly or mainly
absorbed
*MD 0200 - Non-active implants
- *MD 0203 - Non-active functional implants
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
exclusion medical devices class III
*MD 0200 - Non-active implants
- *MD 0204 - Non-active soft tissue implants
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
exclusion medical devices class III
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
Annex II
Annex V
Annex VI
exclusion medical devices class III
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
97 / 301
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care
- *MD 0302 - Suture material and clamps
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
exclusion medical devices class III
*MD 0300 - Devices for wound care
- *MD 0303 - Other medical devices for wound care
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
exclusion medical devices class III
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
Annex II
Annex V
Annex VI
exclusion medical devices class III
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
98 / 301
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories
- *MD 0402 - Dental materials
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
exclusion medical devices class III
*MD 0400 - Non-active dental devices and accessories
- *MD 0403 - Dental implants
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
exclusion medical devices class III,
except dental implants utilizing
biological active coatings and/or
materials or being wholly or mainly
absorbed
*MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
Annex II
Annex V
Annex VI
exclusion medical devices class III
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
99 / 301
conformity (product quality
assurance)
*MD 1100 - General active medical devices
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
exclusion medical devices class III
*MD 1100 - General active medical devices
- *MD 1103 - Devices for stimulation or inhibition
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
exclusion medical devices class III
*MD 1100 - General active medical devices
- *MD 1104 - Active surgical devices
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
Annex II
Annex V
Annex VI
exclusion medical devices class III
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
100 / 301
assurance)
*MD 1100 - General active medical devices
- *MD 1105 - Active ophthalmologic devices
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
exclusion medical devices class III
*MD 1100 - General active medical devices
- *MD 1106 - Active dental devices
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
exclusion medical devices class III
*MD 1100 - General active medical devices
- *MD 1107 - Active devices for disinfection and
sterilisation
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
exclusion medical devices class III
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
101 / 301
*MD 1100 - General active medical devices
- *MD 1108 - Active rehabilitation devices and active
prostheses
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
exclusion medical devices class III
*MD 1100 - General active medical devices
- *MD 1111 - Software
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
exclusion medical devices class III
*MD 1200 - Devices for imaging
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
exclusion medical devices class III
*MD 1300 - Monitoring devices EC declaration of Annex II exclusion medical devices class III
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
102 / 301
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex V
Annex VI
*MD 1300 - Monitoring devices
- *MD 1302 - Monitoring devices of vital physiological
parameters
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
exclusion medical devices class III
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1402 - Devices utilising non-ionizing radiation
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
exclusion medical devices class III
*MD 1400 - Devices for radiation therapy and thermo
therapy
EC declaration of
conformity (full quality
Annex II
Annex V
exclusion medical devices class III
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
103 / 301
- *MD 1403 - Devices for hyperthermia / hypothermia assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex VI
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
exclusion medical devices class III
*MDS 7006 - Medical devices in sterile condition exclusion medical devices class III,
except surgically devices, intended
for transient use, in direct contact
with central nervous system; hip,
knee and shoulder joint
replacements and orthopaedic and
dental implants utilizing biological
active coatings and/or materials or
being wholly or mainly absorbed
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
Orthopaedic and dental implants
only
Materialprüfungsamt Nordrhein-Westfalen(MPA NRW)Marsbruchstraße 18644287 DortmundGermany
0432 *MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
DNV GL Business Assurance Norway ASVeritasveien 11322 HOVIK
0434 *MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
Full quality assurance
system
Annex II
Annex V
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
104 / 301
Norway instruments
- *MD 0402 - Dental materials
- *MD 0403 - Dental implants
*MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
- *MD 1103 - Devices for stimulation or inhibition
- *MD 1104 - Active surgical devices
- *MD 1105 - Active ophthalmologic devices
- *MD 1106 - Active dental devices
- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1108 - Active rehabilitation devices and active
prostheses
- *MD 1109 - Active devices for patient positioning and
transport
- *MD 1110 - Active devices for in vitro fertilisation
(IVF) and assisted reproductive therapy (ART)
- *MD 1111 - Software
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
Production quality
assurance
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
105 / 301
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
- *MD 1302 - Monitoring devices of vital physiological
parameters
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
- *MD 1402 - Devices utilising non-ionizing radiation
- *MD 1403 - Devices for hyperthermia / hypothermia
- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
- *MD 0104 - Non-active medical devices with
measuring function
- *MD 0105 - Non-active ophthalmologic devices
- *MD 0101 - Non-active devices for anaesthesia,
emergency and intensive care
- *MD 0106 - Non-active instruments
- *MD 0107 - Contraceptive medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
106 / 301
- *MD 0109 - Non-active devices for in vitro fertilisation
(IVF) and assisted reproductive technologies (ART)
*MD 0200 - Non-active implants
- *MD 0201 - Non-active cardiovascular implants
- *MD 0202 - Non-active orthopaedic implants
- *MD 0203 - Non-active functional implants
- *MD 0204 - Non-active soft tissue implants
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
- *MD 0302 - Suture material and clamps
- *MD 0303 - Other medical devices for wound care
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
*MDS 7003 - Medical devices incorporating derivates of
human blood, according to Directive 2000/70/EC,
amended by Directive 2001/104/EC
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
DNV is also a NB for that directive
*MDS 7006 - Medical devices in sterile condition
*MDS 7007 - Medical devices utilising micromechanics
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
107 / 301
Laboratoire national d'essais / G-MED1, rue Gaston Boissier75724 PARIS Cedex 15France
0459 *MD 0100 - General non-active, non-implantable
medical devices
- *MD 0101 - Non-active devices for anaesthesia,
emergency and intensive care
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
- *MD 0104 - Non-active medical devices with
measuring function
- *MD 0105 - Non-active ophthalmologic devices
- *MD 0106 - Non-active instruments
- *MD 0107 - Contraceptive medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
- *MD 0109 - Non-active devices for in vitro fertilisation
(IVF) and assisted reproductive technologies (ART)
*MD 0200 - Non-active implants
- *MD 0201 - Non-active cardiovascular implants
- *MD 0202 - Non-active orthopaedic implants
- *MD 0203 - Non-active functional implants
- *MD 0204 - Non-active soft tissue implants
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
- *MD 0302 - Suture material and clamps
- *MD 0303 - Other medical devices for wound care
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
108 / 301
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
- *MD 0402 - Dental materials
- *MD 0403 - Dental implants
*MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
- *MD 1103 - Devices for stimulation or inhibition
- *MD 1104 - Active surgical devices
- *MD 1105 - Active ophthalmologic devices
- *MD 1106 - Active dental devices
- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1108 - Active rehabilitation devices and active
prostheses
- *MD 1109 - Active devices for patient positioning and
transport
- *MD 1110 - Active devices for in vitro fertilisation
(IVF) and assisted reproductive therapy (ART)
- *MD 1111 - Software
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
109 / 301
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
- *MD 1302 - Monitoring devices of vital physiological
parameters
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
- *MD 1402 - Devices utilising non-ionizing radiation
- *MD 1403 - Devices for hyperthermia / hypothermia
- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
*MDS 7003 - Medical devices incorporating derivates of
human blood, according to Directive 2000/70/EC,
amended by Directive 2001/104/EC
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7005 - Medical devices referencing the Directive
89/686/EEC on personal protective equipment (PPE)
*MDS 7006 - Medical devices in sterile condition
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
110 / 301
*MDS 7007 - Medical devices utilising micromechanics
*MDS 7008 - Medical devices utilising nanomaterials
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbedNEMKO ASGaustadalleen 30 - PO Box 73 Blindern0314 OSLONorway
0470 Devices manufactured utilizing animal tissue covered by
Directive 2003/32/EC are excluded:
All medical devices, except X-radiation and particle
radiation equipment for diagnostic and therapeutic use
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
AMTAC CERTIFICATION SERVICES LTDDavy Avenue, KnowlhillMilton Keynes MK5 8NLUnited Kingdom
0473 *MD 0100 - General non-active, non-implantable
medical devices
- *MD 0101 - Non-active devices for anaesthesia,
emergency and intensive care
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
- *MD 0104 - Non-active medical devices with
measuring function
- *MD 0105 - Non-active ophthalmologic devices
- *MD 0106 - Non-active instruments
- *MD 0107 - Contraceptive medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
111 / 301
- *MD 0109 - Non-active devices for in vitro fertilisation
(IVF) and assisted reproductive technologies (ART)
*MD 0200 - Non-active implants
- *MD 0201 - Non-active cardiovascular implants
- *MD 0202 - Non-active orthopaedic implants
- *MD 0203 - Non-active functional implants
- *MD 0204 - Non-active soft tissue implants
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
- *MD 0302 - Suture material and clamps
- *MD 0303 - Other medical devices for wound care
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
- *MD 0402 - Dental materials
- *MD 0403 - Dental implants
*MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
- *MD 1103 - Devices for stimulation or inhibition
- *MD 1104 - Active surgical devices
- *MD 1105 - Active ophthalmologic devices
- *MD 1106 - Active dental devices
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
112 / 301
- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1108 - Active rehabilitation devices and active
prostheses
- *MD 1109 - Active devices for patient positioning and
transport
- *MD 1110 - Active devices for in vitro fertilisation
(IVF) and assisted reproductive therapy (ART)
- *MD 1111 - Software
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
- *MD 1302 - Monitoring devices of vital physiological
parameters
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
- *MD 1402 - Devices utilising non-ionizing radiation
- *MD 1403 - Devices for hyperthermia / hypothermia
- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)
*MDS 7001 - Medical devices incorporating medicinal
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
113 / 301
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
*MDS 7006 - Medical devices in sterile condition
*MDS 7007 - Medical devices utilising micromechanics
*MDS 7008 - Medical devices utilising nanomaterials
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbedKIWA CERMET ITALIA S.P.A.Via Cadriano, 2340057 - Cadriano di Granarolo (BO)Italy
0476 *MD 0200 - Non-active implants
- *MD 0202 - Non-active orthopaedic implants
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices,
except hip, knee and shoulder joint
replacements.
*MD 0200 - Non-active implants
- *MD 0203 - Non-active functional implants
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
114 / 301
*MD 0200 - Non-active implants
- *MD 0204 - Non-active soft tissue implants
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 0300 - Devices for wound care
- *MD 0302 - Suture material and clamps
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 0300 - Devices for wound care EC declaration of Annex II Excluding class III medical devices
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
115 / 301
- *MD 0303 - Other medical devices for wound care conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex V
Annex VI
*MD 0400 - Non-active dental devices and accessories
- *MD 0402 - Dental materials
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 0400 - Non-active dental devices and accessories
- *MD 0403 - Dental implants
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
EC declaration of
conformity (full quality
Annex II
Annex V
Excluding class III medical devices
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
116 / 301
instruments assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0101 - Non-active devices for anaesthesia,
emergency and intensive care
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices,
except surgically devices, intended
for transient use, in direct contact
with central nervous system
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0104 - Non-active medical devices with
EC declaration of
conformity (full quality
assurance system)
Annex II
Annex V
Annex VI
Excluding class III medical devices
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
117 / 301
measuring function EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0105 - Non-active ophthalmologic devices
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0106 - Non-active instruments
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0107 - Contraceptive medical devices
EC declaration of
conformity (full quality
assurance system)
EC declaration of
Annex II
Annex V
Annex VI
Excluding class III medical devices
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
118 / 301
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 1100 - General active medical devices
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
Annex II
Annex V
Annex VI
Excluding class III medical devices
and hyperbaric chambers for
oxygen therapy
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
119 / 301
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices
- *MD 1103 - Devices for stimulation or inhibition
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 1100 - General active medical devices
- *MD 1104 - Active surgical devices
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 1100 - General active medical devices
- *MD 1105 - Active ophthalmologic devices
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
120 / 301
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices
- *MD 1106 - Active dental devices
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 1100 - General active medical devices
- *MD 1107 - Active devices for disinfection and
sterilisation
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 1100 - General active medical devices
- *MD 1108 - Active rehabilitation devices and active
prostheses
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
Annex II
Annex V
Annex VI
Excluding class III medical devices
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
121 / 301
conformity (product quality
assurance)
*MD 1100 - General active medical devices
- *MD 1109 - Active devices for patient positioning and
transport
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 1100 - General active medical devices
- *MD 1111 - Software
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 1200 - Devices for imaging
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
Annex II
Annex V
Annex VI
Excluding class III medical devices
and devices for magnetic
resonance
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
122 / 301
assurance)
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 1300 - Monitoring devices
- *MD 1302 - Monitoring devices of vital physiological
parameters
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1403 - Devices for hyperthermia / hypothermia
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
123 / 301
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
Excluding class III medical devices
*MDS 7006 - Medical devices in sterile condition Excluding class III medical devices,
except surgically devices, intended
for transient use, in direct contact
with central nervous system; hip,
knee and shoulder joint
replacementsEurofins Product Testing Italy S.r.l.Via Courgnè, 2110156 - TORINO (TO)Italy
0477 *MD 0100 - General non-active, non-implantable
medical devices
- *MD 0101 - Non-active devices for anaesthesia,
emergency and intensive care
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 0100 - General non-active, non-implantable
medical devices
EC type-examination
EC verification
Annex III
Annex IV
Excluding class III medical devices
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
124 / 301
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0104 - Non-active medical devices with
measuring function
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 0100 - General non-active, non-implantable EC type-examination Annex III Excluding class III medical devices
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
125 / 301
medical devices
- *MD 0105 - Non-active ophthalmologic devices
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex IV
Annex II
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0106 - Non-active instruments
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0107 - Contraceptive medical devices
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
Annex III
Annex IV
Annex II
Annex V
Annex VI
Excluding class III medical devices
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
126 / 301
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 0200 - Non-active implants
- *MD 0202 - Non-active orthopaedic implants
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 0200 - Non-active implants
- *MD 0203 - Non-active functional implants
EC type-examination
EC verification
EC declaration of
conformity (full quality
Annex III
Annex IV
Annex II
Excluding class III medical devices
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
127 / 301
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex V
Annex VI
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 0300 - Devices for wound care
- *MD 0302 - Suture material and clamps
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
Annex III
Annex IV
Annex II
Annex V
Annex VI
Excluding class III medical devices
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
128 / 301
assurance)
*MD 0300 - Devices for wound care
- *MD 0303 - Other medical devices for wound care
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 0400 - Non-active dental devices and accessories
- *MD 0402 - Dental materials
EC type-examination
EC verification
EC declaration of
conformity (full quality
Annex III
Annex IV
Annex II
Annex V
Excluding class III medical devices
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
129 / 301
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex VI
*MD 0400 - Non-active dental devices and accessories
- *MD 0403 - Dental implants
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
130 / 301
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1103 - Devices for stimulation or inhibition
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Only class IIa medical devices
*MD 1100 - General active medical devices
- *MD 1104 - Active surgical devices
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 1100 - General active medical devices
- *MD 1105 - Active ophthalmologic devices
EC declaration of
conformity (full quality
Annex II
Annex V
Excluding class III medical devices
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
131 / 301
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex VI
*MD 1100 - General active medical devices
- *MD 1106 - Active dental devices
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 1100 - General active medical devices
- *MD 1107 - Active devices for disinfection and
sterilisation
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 1100 - General active medical devices
- *MD 1108 - Active rehabilitation devices and active
prostheses
EC declaration of
conformity (full quality
assurance system)
Annex II
Annex V
Annex VI
Excluding class III medical devices
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
132 / 301
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices
- *MD 1109 - Active devices for patient positioning and
transport
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 1100 - General active medical devices
- *MD 1111 - Software
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
EC declaration of
conformity (full quality
assurance system)
EC declaration of
Annex II
Annex V
Annex VI
Excluding class III medical devices
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
133 / 301
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1200 - Devices for imaging
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
and devices for magnetic
resonance
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
Annex II
Annex V
Annex VI
Excluding class III medical devices
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
134 / 301
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1402 - Devices utilising non-ionizing radiation
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
Excluding class III medical devices
*MDS 7005 - Medical devices referencing the Directive
89/686/EEC on personal protective equipment (PPE)
Excluding class III medical devices
*MDS 7006 - Medical devices in sterile condition Excluding class III medical devicesECM-ZERTIFIZIERUNGSGESELLSCHAFT 0481 *MD 0100 - General non-active, non-implantable Full quality assurance Annex II
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
135 / 301
FÜR MEDIZINPRODUKTE IN EUROPA MBHBismarckstraße 10652066 AACHENGermany
medical devices
- *MD 0101 - Non-active devices for anaesthesia,
emergency and intensive care
system
Production quality
assurance
Product quality assurance
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
Full quality assurance
system
EC type-examination
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex V
Annex VI
Annex III: Only infusion sets,
transfusion sets, catheters, tubing
systems for extra-corporal
circulation
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0104 - Non-active medical devices with
measuring function
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0105 - Non-active ophthalmologic devices
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
Full quality assurance
system
Annex II
Annex V
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
136 / 301
- *MD 0106 - Non-active instruments Production quality
assurance
Product quality assurance
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0107 - Contraceptive medical devices
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0109 - Non-active devices for in vitro fertilisation
(IVF) and assisted reproductive technologies (ART)
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0200 - Non-active implants
- *MD 0201 - Non-active cardiovascular implants
Full quality assurance
system
EC type-examination
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex V
Annex VI
Only stents, implantable catheters,
vascular grafts, occlusion systems
*MD 0200 - Non-active implants
- *MD 0202 - Non-active orthopaedic implants
Full quality assurance
system
Production quality
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
137 / 301
assurance
Product quality assurance
*MD 0200 - Non-active implants
- *MD 0203 - Non-active functional implants
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
Only introcular lenses
*MD 0200 - Non-active implants
- *MD 0204 - Non-active soft tissue implants
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0300 - Devices for wound care
- *MD 0302 - Suture material and clamps
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0300 - Devices for wound care
- *MD 0303 - Other medical devices for wound care
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
138 / 301
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0400 - Non-active dental devices and accessories
- *MD 0402 - Dental materials
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0400 - Non-active dental devices and accessories
- *MD 0403 - Dental implants
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
Only devices with existing TSE
Certificate of Suitability for the
starting materials issued by the
European Directorate for the
Qualits of Medicines (EDQM)
*MDS 7006 - Medical devices in sterile condition
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbedMEDCERT ZERTIFIZIERUNGS- UNDPRÜFUNGSGESELLSCHAFT FÜR DIE
0482 *MD 0100 - General non-active, non-implantable Full quality assurance Annex II
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
139 / 301
MEDIZIN GMBHPilatuspool 220355 HAMBURGGermany
medical devices
- *MD 0101 - Non-active devices for anaesthesia,
emergency and intensive care
system
Production quality
assurance
Product quality assurance
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
- *MD 0104 - Non-active medical devices with
measuring function
- *MD 0105 - Non-active ophthalmologic devices
- *MD 0106 - Non-active instruments
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0107 - Contraceptive medical devices
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
140 / 301
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
- *MD 0109 - Non-active devices for in vitro fertilisation
(IVF) and assisted reproductive technologies (ART)
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0200 - Non-active implants
- *MD 0201 - Non-active cardiovascular implants
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
*MD 0200 - Non-active implants
- *MD 0202 - Non-active orthopaedic implants
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0200 - Non-active implants
- *MD 0203 - Non-active functional implants
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
*MD 0200 - Non-active implants
- *MD 0204 - Non-active soft tissue implants
Full quality assurance
system
Annex II
Annex V
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
141 / 301
Production quality
assurance
Product quality assurance
Annex VI
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
*MD 0300 - Devices for wound care
- *MD 0302 - Suture material and clamps
- *MD 0303 - Other medical devices for wound care
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
- *MD 0402 - Dental materials
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0400 - Non-active dental devices and accessories
- *MD 0403 - Dental implants
*MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
- *MD 1103 - Devices for stimulation or inhibition
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
142 / 301
- *MD 1104 - Active surgical devices
- *MD 1105 - Active ophthalmologic devices
- *MD 1106 - Active dental devices
- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1108 - Active rehabilitation devices and active
prostheses
- *MD 1109 - Active devices for patient positioning and
transport
- *MD 1111 - Software
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
- *MD 1302 - Monitoring devices of vital physiological
parameters
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
- *MD 1402 - Devices utilising non-ionizing radiation
- *MD 1403 - Devices for hyperthermia / hypothermia
- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
143 / 301
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
for active medical devices only
*MDS 7006 - Medical devices in sterile condition
*MDS 7007 - Medical devices utilising micromechanics
*MDS 7008 - Medical devices utilising nanomaterials
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbedMDC MEDICAL DEVICE CERTIFICATIONGMBHKriegerstrasse 670191 STUTTGARTGermany
0483 *MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1200 - Devices for imaging
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
Full quality assurance
system
Production quality
assurance
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
144 / 301
Product quality assurance
*MD 1300 - Monitoring devices
- *MD 1302 - Monitoring devices of vital physiological
parameters
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1402 - Devices utilising non-ionizing radiation
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0101 - Non-active devices for anaesthesia,
emergency and intensive care
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
145 / 301
medical devices
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
system
Production quality
assurance
Product quality assurance
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0104 - Non-active medical devices with
measuring function
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0105 - Non-active ophthalmologic devices
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0106 - Non-active instruments
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0107 - Contraceptive medical devices
Full quality assurance
system
Production quality
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
146 / 301
assurance
Product quality assurance
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0109 - Non-active devices for in vitro fertilisation
(IVF) and assisted reproductive technologies (ART)
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0200 - Non-active implants
- *MD 0201 - Non-active cardiovascular implants
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0200 - Non-active implants
- *MD 0202 - Non-active orthopaedic implants
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
*MD 0200 - Non-active implants Full quality assurance Annex II
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
147 / 301
- *MD 0203 - Non-active functional implants system
Production quality
assurance
Product quality assurance
Annex V
Annex VI
*MD 0200 - Non-active implants
- *MD 0204 - Non-active soft tissue implants
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0300 - Devices for wound care
- *MD 0302 - Suture material and clamps
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0300 - Devices for wound care
- *MD 0303 - Other medical devices for wound care
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
Full quality assurance
system
Production quality
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
148 / 301
assurance
Product quality assurance
*MD 0400 - Non-active dental devices and accessories
- *MD 0402 - Dental materials
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0400 - Non-active dental devices and accessories
- *MD 0403 - Dental implants
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1106 - Active dental devices
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1107 - Active devices for disinfection and
sterilisation
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1108 - Active rehabilitation devices and active
prostheses
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
149 / 301
*MD 1100 - General active medical devices
- *MD 1109 - Active devices for patient positioning and
transport
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1111 - Software
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
except hyperbaric chambers
*MD 1100 - General active medical devices
- *MD 1103 - Devices for stimulation or inhibition
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
except external pacemakers and
heart defibrillators
*MD 1100 - General active medical devices
- *MD 1104 - Active surgical devices
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1105 - Active ophthalmologic devices
Full quality assurance
system
Annex II
Annex V
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
150 / 301
Production quality
assurance
Product quality assurance
Annex VI
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
for active medical devices only
*MDS 7006 - Medical devices in sterile condition
*MDS 7008 - Medical devices utilising nanomaterials
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbedSLG PRÜF UND ZERTIFIZIERUNGS GMBHBurgstädter Strasse 2009232 HartmannsdorfGermany
0494 *MD 1100 - General active medical devices
- *MD 1103 - Devices for stimulation or inhibition
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
- *MD 1104 - Active surgical devices
- *MD 1105 - Active ophthalmologic devices
- *MD 1106 - Active dental devices
- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1108 - Active rehabilitation devices and active
prostheses
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
151 / 301
- *MD 1109 - Active devices for patient positioning and
transport
- *MD 1111 - Software
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
- *MD 1302 - Monitoring devices of vital physiological
parameters
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
- *MD 1402 - Devices utilising non-ionizing radiation
- *MD 1403 - Devices for hyperthermia / hypothermia
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinerySOCIETE NATIONALE DE CERTIFICATIONET D'HOMOLOGATION S.À.R.L. (SNCH)2a. KalchesbruckL-1852 LUXEMBOURGLuxembourg
0499 All medical devices Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
152 / 301
BSI Group Deutschland GmbHHanauer Landstrasse 11560314 Frankfurt am MainGermany
0535 *MD 0100 - General non-active, non-implantable
medical devices
- *MD 0101 - Non-active devices for anaesthesia,
emergency and intensive care
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
- *MD 0104 - Non-active medical devices with
measuring function
- *MD 0106 - Non-active instruments
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
*MD 0200 - Non-active implants
- *MD 0201 - Non-active cardiovascular implants
- *MD 0202 - Non-active orthopaedic implants
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
- *MD 0302 - Suture material and clamps
- *MD 0303 - Other medical devices for wound care
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
- *MD 0402 - Dental materials
- *MD 0403 - Dental implants
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1100 - General active medical devices Full quality assurance Annex II
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
153 / 301
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
- *MD 1103 - Devices for stimulation or inhibition
- *MD 1104 - Active surgical devices
- *MD 1105 - Active ophthalmologic devices
- *MD 1106 - Active dental devices
- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1108 - Active rehabilitation devices and active
prostheses
- *MD 1109 - Active devices for patient positioning and
transport
- *MD 1111 - Software
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
- *MD 1302 - Monitoring devices of vital physiological
parameters
*MD 1400 - Devices for radiation therapy and thermo
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex III
Annex IV
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
154 / 301
therapy
- *MD 1401 - Devices utilising ionizing radiation
- *MD 1402 - Devices utilising non-ionizing radiation
- *MD 1403 - Devices for hyperthermia / hypothermia
- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
For active medical devices only
*MDS 7006 - Medical devices in sterile conditionVTT Expert Services OyPO Box 345FI-33101 TampereFinland
0537 *MD 0100 - General non-active, non-implantable
medical devices
- *MD 0101 - Non-active devices for anaesthesia,
emergency and intensive care
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III
*MD 0200 - Non-active implants
- *MD 0202 - Non-active orthopaedic implants
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
Annex II
Annex V
Annex VI
Excluding class III
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
155 / 301
conformity (product quality
assurance)
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III
*MD 1100 - General active medical devices
- *MD 1103 - Devices for stimulation or inhibition
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
Annex II
Annex V
Annex VI
Excluding class III
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
156 / 301
assurance)
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1402 - Devices utilising non-ionizing radiation
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
157 / 301
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0104 - Non-active medical devices with
measuring function
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
158 / 301
medical devices
- *MD 0105 - Non-active ophthalmologic devices
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0106 - Non-active instruments
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III
*MD 0300 - Devices for wound care
- *MD 0303 - Other medical devices for wound care
EC declaration of
conformity (full quality
Annex II
Annex V
Excluding class III
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
159 / 301
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex VI
*MD 0400 - Non-active dental devices and accessories
- *MD 0402 - Dental materials
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III
*MD 0400 - Non-active dental devices and accessories
- *MD 0403 - Dental implants
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III
*MD 1100 - General active medical devices
- *MD 1104 - Active surgical devices
EC declaration of
conformity (full quality
assurance system)
Annex II
Annex V
Annex VI
Excluding class III
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
160 / 301
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices
- *MD 1105 - Active ophthalmologic devices
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III
*MD 1100 - General active medical devices
- *MD 1106 - Active dental devices
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III
*MD 1100 - General active medical devices
- *MD 1107 - Active devices for disinfection and
sterilisation
EC declaration of
conformity (full quality
assurance system)
EC declaration of
Annex II
Annex V
Annex VI
Excluding class III
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
161 / 301
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices
- *MD 1108 - Active rehabilitation devices and active
prostheses
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III
*MD 1100 - General active medical devices
- *MD 1111 - Software
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III
*MD 1200 - Devices for imaging
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
Annex II
Annex V
Annex VI
Excluding class III
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
162 / 301
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices
- *MD 1302 - Monitoring devices of vital physiological
parameters
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1403 - Devices for hyperthermia / hypothermia
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
Excluding class III
*MDS 7006 - Medical devices in sterile condition Including aseptic processing,
ethylene oxide gas sterilisation
(EOG), low temperature steam and
formaldehyde sterilisation, moist
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
163 / 301
heat sterilisation (gamma, x-ray,
electron beam), others (need to be
specified)Presafe Denmark A/STuborg Parkvej 8DK-2900 HellerupDenmark
0543 *MD 0100 - General non-active, non-implantable
medical devices
- *MD 0101 - Non-active devices for anaesthesia,
emergency and intensive care
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0104 - Non-active medical devices with
measuring function
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
164 / 301
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0105 - Non-active ophthalmologic devices
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0106 - Non-active instruments
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
165 / 301
assurance)
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0109 - Non-active devices for in vitro fertilisation
(IVF) and assisted reproductive technologies (ART)
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
*MD 0200 - Non-active implants
- *MD 0202 - Non-active orthopaedic implants
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding orthopaedic implants ref.
2005/50/EEC and bone cement
*MD 0200 - Non-active implants
- *MD 0203 - Non-active functional implants
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
166 / 301
*MD 0200 - Non-active implants
- *MD 0204 - Non-active soft tissue implants
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
*MD 0300 - Devices for wound care
- *MD 0302 - Suture material and clamps
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
*MD 0300 - Devices for wound care EC declaration of Annex II
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
167 / 301
- *MD 0303 - Other medical devices for wound care conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1104 - Active surgical devices
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1106 - Active dental devices
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1107 - Active devices for disinfection and
EC declaration of
conformity (full quality
Annex II
Annex V
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
168 / 301
sterilisation assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex VI
*MD 1100 - General active medical devices
- *MD 1110 - Active devices for in vitro fertilisation
(IVF) and assisted reproductive therapy (ART)
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1111 - Software
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
EC declaration of
conformity (full quality
assurance system)
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
169 / 301
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1103 - Devices for stimulation or inhibition
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
EC declaration of
conformity (full quality
assurance system)
EC declaration of
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
170 / 301
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1200 - Devices for imaging
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
*MD 1300 - Monitoring devices
- *MD 1302 - Monitoring devices of vital physiological
parameters
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
171 / 301
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1402 - Devices utilising non-ionizing radiation
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
Only products not included in
Directive 2003/32/EC
*MDS 7003 - Medical devices incorporating derivates of
human blood, according to Directive 2000/70/EC,
amended by Directive 2001/104/EC
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
172 / 301
/utilising software /controlled by softwareCERTIQUALITY S.R.L. - ISTITUTO DICERTIFICAZIONE DELLA QUALITA'Via G. Giardino, 420123 - MILANOItaly
0546 *MD 0100 - General non-active, non-implantable
medical devices
- *MD 0101 - Non-active devices for anaesthesia,
emergency and intensive care
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Exclusion medical devices class III
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Exclusion medical devices class III
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Exclusion medical devices class III
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
173 / 301
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0104 - Non-active medical devices with
measuring function
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Exclusion medical devices class III
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0105 - Non-active ophthalmologic devices
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Exclusion medical devices class III
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0106 - Non-active instruments
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Exclusion medical devices class III
*MD 0100 - General non-active, non-implantable EC declaration of Annex II Exclusion medical devices class III
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
174 / 301
medical devices
- *MD 0107 - Contraceptive medical devices
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Exclusion medical devices class III
*MD 0200 - Non-active implants
- *MD 0202 - Non-active orthopaedic implants
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Exclusion medical devices class III
*MD 0200 - Non-active implants
- *MD 0203 - Non-active functional implants
EC declaration of
conformity (full quality
Annex II
Annex V
Exclusion medical devices class III
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
175 / 301
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex VI
*MD 0200 - Non-active implants
- *MD 0204 - Non-active soft tissue implants
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Exclusion medical devices class III
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Exclusion medical devices class III
*MD 0300 - Devices for wound care
- *MD 0302 - Suture material and clamps
EC declaration of
conformity (full quality
assurance system)
Annex II
Annex V
Annex VI
Exclusion medical devices class III
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
176 / 301
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care
- *MD 0303 - Other medical devices for wound care
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Exclusion medical devices class III
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Exclusion medical devices class III
*MD 0400 - Non-active dental devices and accessories
- *MD 0402 - Dental materials
EC declaration of
conformity (full quality
assurance system)
EC declaration of
Annex II
Annex V
Annex VI
Exclusion medical devices class III
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
177 / 301
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories
- *MD 0403 - Dental implants
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Exclusion medical devices class III
*MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Only those charged with
indipendent power source.
Exclusion medical devices class III
*MD 1100 - General active medical devices
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
Annex II
Annex V
Annex VI
Only those charged with
indipendent power source.
Exclusion hyperbaric chambers.
Exclusion medical devices class III
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
178 / 301
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices
- *MD 1104 - Active surgical devices
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Only those charged with
indipendent power
source.Exclusion medical devices
class III
*MD 1100 - General active medical devices
- *MD 1106 - Active dental devices
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Only those charged with
indipendent power
source.Exclusion medical devices
class III
*MD 1100 - General active medical devices
- *MD 1111 - Software
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
Annex II
Annex V
Annex VI
Exclusion medical devices class III
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
179 / 301
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Only those charged with
indipendent power
source.Exclusion medical devices
class III
*MD 1300 - Monitoring devices
- *MD 1302 - Monitoring devices of vital physiological
parameters
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Only those charged with
indipendent power
source.Exclusion medical devices
class III
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1403 - Devices for hyperthermia / hypothermia
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
Annex II
Annex V
Annex VI
Only those charged with
indipendent power
source.Exclusion medical devices
class III
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
180 / 301
conformity (product quality
assurance)
*MDS 7006 - Medical devices in sterile condition Exclusion medical devices class IIISGS FIMKO OYP.O. Box 30 (Särkiniementie 3)00211 HELSINKIFinland
0598 *MD 0100 - General non-active, non-implantable
medical devices
- *MD 0101 - Non-active devices for anaesthesia,
emergency and intensive care
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
II: Up to class IIb only
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
II: Up to class IIb only
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0104 - Non-active medical devices with
measuring function
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex VI
II: Up to class IIb only
*MD 0100 - General non-active, non-implantable EC declaration of Annex II II: Up to class IIb only
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
181 / 301
medical devices
- *MD 0106 - Non-active instruments
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
II: Up to class IIb only
*MD 0200 - Non-active implants
- *MD 0202 - Non-active orthopaedic implants
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
II: Up to class IIb only
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
EC declaration of
conformity (full quality
Annex II
Annex V
II: Up to class IIb only
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
182 / 301
instruments assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex VI
*MD 0400 - Non-active dental devices and accessories
- *MD 0402 - Dental materials
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
II: Up to class IIb only
*MD 0400 - Non-active dental devices and accessories
- *MD 0403 - Dental implants
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
II: Up to class IIb only
*MD 1100 - General active medical devices
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
EC type-examination
EC verification
EC declaration of
Annex III
Annex IV
Annex II
II: Up to class IIb only; III, IV:
Hyperbaric chambers only
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
183 / 301
anaesthesia conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1103 - Devices for stimulation or inhibition
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
II: Up to class IIb only; III, IV: Nerve
and muscle stimulator only
*MD 1100 - General active medical devices
- *MD 1104 - Active surgical devices
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
II: Up to class IIb only
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
184 / 301
*MD 1100 - General active medical devices
- *MD 1105 - Active ophthalmologic devices
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
II: Up to class IIb only
*MD 1100 - General active medical devices
- *MD 1106 - Active dental devices
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
II: Up to class IIb only; III, IV:
Dental units and dental patient
chairs only
*MD 1100 - General active medical devices
- *MD 1107 - Active devices for disinfection and
sterilisation
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
Annex II
Annex V
Annex VI
II: Up to class IIb only
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
185 / 301
assurance)
*MD 1100 - General active medical devices
- *MD 1108 - Active rehabilitation devices and active
prostheses
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
II: Up to class IIb only; III, IV:
Neurological and muscular
rehabilitation devices only
*MD 1100 - General active medical devices
- *MD 1109 - Active devices for patient positioning and
transport
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
II: Up to class IIb only
*MD 1100 - General active medical devices
- *MD 1111 - Software
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
Annex II
Annex V
Annex VI
II: Up to class IIb only
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
186 / 301
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
II: Up to class IIb only; III, IV: X-ray
devices only
*MD 1200 - Devices for imaging
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
II: Up to class IIb only; III, IV:
Magnetic resonance imaging (MRI)
devices only
*MD 1300 - Monitoring devices EC type-examination Annex III II: Up to class IIb only
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
187 / 301
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex IV
Annex II
Annex V
Annex VI
*MD 1300 - Monitoring devices
- *MD 1302 - Monitoring devices of vital physiological
parameters
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
II: Up to class IIb only
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
Annex II
Annex V
Annex VI
II: Up to class IIb only
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
188 / 301
conformity (product quality
assurance)
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1402 - Devices utilising non-ionizing radiation
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
II: Up to class IIb only; III, IV:
Surgical ultrasoud devices only
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1403 - Devices for hyperthermia / hypothermia
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
II: Up to class IIb only
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
II: Up to class IIb only
*MDS 7006 - Medical devices in sterile condition II: Up to class IIb onlyBERLIN CERT PRÜF- UNDZERTIFIZIERSTELLE FÜRMEDIZINPRODUKTE GMBH AN DERTECHNISCHEN UNIVERSITÄT BERLIN
0633 *MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
EC type-examination
EC verification
Annex III
Annex IV
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
189 / 301
Dovestraße 610587 BERLINGermany
*MD 1100 - General active medical devices
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
Except hyperbaric chambers
*MD 1100 - General active medical devices
- *MD 1103 - Devices for stimulation or inhibition
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1104 - Active surgical devices
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1105 - Active ophthalmologic devices
EC type-examination
EC verification
Annex III
Annex IV
*MD 1100 - General active medical devices Full quality assurance Annex II
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
190 / 301
- *MD 1106 - Active dental devices system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex III
Annex IV
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1107 - Active devices for disinfection and
sterilisation
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1108 - Active rehabilitation devices and active
prostheses
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1109 - Active devices for patient positioning and
transport
EC type-examination
EC verification
Annex III
Annex IV
*MD 1100 - General active medical devices
- *MD 1111 - Software
EC type-examination
EC verification
Annex III
Annex IV
*MD 1200 - Devices for imaging Full quality assurance Annex II Except magnetic resonance
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
191 / 301
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex III
Annex IV
Annex V
Annex VI
imaging
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
*MD 1300 - Monitoring devices
- *MD 1302 - Monitoring devices of vital physiological
parameters
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1402 - Devices utilising non-ionizing radiation
EC type-examination
EC verification
Annex III
Annex IV
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1403 - Devices for hyperthermia / hypothermia
EC type-examination
EC verification
Annex III
Annex IV
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
192 / 301
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile conditionPRÜFSTELLE FÜR MEDIZINPRODUKTEGRAZKopernikusgasse 24/18010 GRAZAustria
0636 *MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
- *MD 1103 - Devices for stimulation or inhibition
- *MD 1104 - Active surgical devices
- *MD 1105 - Active ophthalmologic devices
- *MD 1106 - Active dental devices
- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1108 - Active rehabilitation devices and active
prostheses
- *MD 1109 - Active devices for patient positioning and
transport
- *MD 1111 - Software
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
193 / 301
physiological parameters
- *MD 1302 - Monitoring devices of vital physiological
parameters
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
- *MD 1402 - Devices utilising non-ionizing radiation
- *MD 1403 - Devices for hyperthermia / hypothermia
- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
- *MD 0104 - Non-active medical devices with
measuring function
- *MD 0105 - Non-active ophthalmologic devices
- *MD 0106 - Non-active instruments
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition
*MDS 7007 - Medical devices utilising micromechanicsNATIONAL EVALUATION CENTER OFQUALITY AND TECHNOLOGY IN HEALTHS.A.- EKAPTYSmyrnis 15
0653 All medical devices Full quality assurance
system
Annex II
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
194 / 301
165 62 GLYFADAGreece
Implantable and non-implantable orthopaedic materials
and devices
Other implantable devices
Artificial limbs and related components for disabled
Bandages, surgical dressings, medical grade cotton and
other relevant products
dental devices
Disinfectants and antiseptics
Contact lenses and solutions for contact lenses
Absorbable and non-absorbable surgical sutures
- disinfectants and antiseptics#
Sterile and non-sterile single use products
Contraceptives
Contact lenses maintenance products
Absorbable and non-absorbable surgical sutures
Sterile and non-sterile single use products
Contraceptives
EC type-examination Annex III
Only devices mentioned in § B EC verification Annex IV
All medical devices Production quality
assurance
Product quality assurance
Annex V
Annex VI
THERAPEUTIC GOODS ADMINISTRATIONPO Box 100ACT 2606 WODENAustralia
0805 All medical devices Full quality assurance
system
EC type-examination
Annex II
Annex III
Annex IV
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
195 / 301
EC verification
Production quality
assurance
Product quality assurance
Annex V
Annex VI
UL INTERNATIONAL (UK) LTDWonersh House Building C The Guildway OldPortsmouth RoadGuildford GU3 1LRUnited Kingdom
0843 Wound dressings (Class IIa and IIb) EC type-examination
EC verification
Annex III
Annex IV
Gloves for medical use
Urethral catheters
EC verification Annex IV
Active medical devices and their accessories Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
Disinfectants and surgical instruments
Sterile single use medical devices excluding Class III
devices, ophthalmic devices, (class IIa and above) and
implants
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
Own Brand Labelling of all medical devices which have
existing NB certification via their original manufacturer
Full quality assurance
system
EC type-examination
EC verification
Production quality
Annex II
Annex III
Annex IV
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
196 / 301
assurance
Product quality assurance
Non-active Class III cardiac catheters Full quality assurance
system
Annex II
All Dental Devices (Non Active) Full quality assurance
system
Production quality
assurance
Annex II
Annex V
TÜV Rheinland InterCert Muszaki Felügyeletiés Tanúsító Korlátolt Felelosségu TársaságVáci út 48/A-B.H-1132 BudapestHungary
1008 *MD 0100 - General non-active, non-implantable
medical devices
- *MD 0101 - Non-active devices for anaesthesia,
emergency and intensive care
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
EC declaration of
conformity (full quality
Annex II
Annex V
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
197 / 301
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0104 - Non-active medical devices with
measuring function
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0105 - Non-active ophthalmologic devices
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0106 - Non-active instruments
EC declaration of
conformity (full quality
assurance system)
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
198 / 301
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0107 - Contraceptive medical devices
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
*MD 0200 - Non-active implants
- *MD 0202 - Non-active orthopaedic implants
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
*MD 0200 - Non-active implants
- *MD 0203 - Non-active functional implants
EC declaration of
conformity (full quality
assurance system)
EC declaration of
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
199 / 301
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants
- *MD 0204 - Non-active soft tissue implants
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
*MD 0300 - Devices for wound care
- *MD 0302 - Suture material and clamps
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
200 / 301
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care
- *MD 0303 - Other medical devices for wound care
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
*MD 0400 - Non-active dental devices and accessories
- *MD 0402 - Dental materials
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
201 / 301
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories
- *MD 0403 - Dental implants
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
For Annex III. and IV. designation
is limited to infusion pumps. For
Annex II., V., VI. there are no
limitations
*MD 1100 - General active medical devices
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
Annex III
Annex IV
Annex II
Annex V
For Annex III. and IV. designation
is limited to baby incubators,
transportable incubators, infant
warmers, oxygen concentrators.
For Annex II., V., VI. there are no
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
202 / 301
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex VI limitations.
*MD 1100 - General active medical devices
- *MD 1103 - Devices for stimulation or inhibition
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Annex III and IV. designation is
limited to defibrillators, nerve and
muscle stimulators,
electroconclusiv therapy
equipments. For Annex II., V., VI.
there are no limitations.
*MD 1100 - General active medical devices
- *MD 1104 - Active surgical devices
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Annex III and IV. designation is
limited to high frequency surgery
equipments, suction equipments.
For Annex II., V., VI. there are no
limitations.
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
203 / 301
*MD 1100 - General active medical devices
- *MD 1105 - Active ophthalmologic devices
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1106 - Active dental devices
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1107 - Active devices for disinfection and
sterilisation
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
*MD 1100 - General active medical devices EC declaration of Annex II
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
204 / 301
- *MD 1108 - Active rehabilitation devices and active
prostheses
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1109 - Active devices for patient positioning and
transport
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Annex III and IV. designation is
limited to electrically operated
hospital beds, operating tables,
wheelchairs (electrically operated).
For Annex II., V., VI. there are no
limitations.
*MD 1100 - General active medical devices
- *MD 1110 - Active devices for in vitro fertilisation
(IVF) and assisted reproductive therapy (ART)
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
205 / 301
*MD 1100 - General active medical devices
- *MD 1111 - Software
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Annex III and IV. designation is
limited to high voltage generators
for diagnostic X-ray generators,
Capacitor charged X-ray
generators, Equipments connected
to X-ray equipments. For Annex II.,
V., VI. there are no limitations.
*MD 1200 - Devices for imaging
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
206 / 301
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Annex III and IV. designation is
limited to Electroencephalographs,
Cyclic indirect blood pressure
measurment devices,
Electromyographs, Audiometers.
For Annex II., V., VI. there are no
limitations.
*MD 1300 - Monitoring devices
- *MD 1302 - Monitoring devices of vital physiological
parameters
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Annex III and IV. designation is
limited to Electrocardiographs,
ECG monitoring equipments,
Transcutane partial pressure
measuring equipments, Direct
blood pressure monitoring
equipments, Pulse oxymeters,
Capnometers, Oxygen monitors.
For Annex II., V., VI. there are no
limitations.
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1402 - Devices utilising non-ionizing radiation
EC type-examination
EC verification
Annex III
Annex IV
Annex III and IV. designation is
limited to short wave devices for
treatment, Ultrasonic therapy
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
207 / 301
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
equipment, Microwave therapy
equipment, Laser equipment
(diagnostic and therapeutic). For
Annex II., V., VI. there are no
limitations.
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1403 - Devices for hyperthermia / hypothermia
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
*MDS 7004 - Medical devices referencing the Directive
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
208 / 301
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile conditionOrszágos Gógyszerészeti ésÉlelmezés-egészségügyi IntézetEszközmin#sít# és KórháztechnikaiIgazgatóság (National Institute of Pharmacyand Nutrition)Zrínyi u. 3H-1051 BudapestHungary
1011 *MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
Annex II
Annex V
*MD 1200 - Devices for imaging
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
*MD 1300 - Monitoring devices
- *MD 1302 - Monitoring devices of vital physiological
parameters
Full quality assurance
system
EC type-examination
EC verification
Production quality
Annex II
Annex III
Annex IV
Annex V
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
209 / 301
assurance
Product quality assurance
Annex VI
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
Annex II
Annex V
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1402 - Devices utilising non-ionizing radiation
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1403 - Devices for hyperthermia / hypothermia
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0101 - Non-active devices for anaesthesia,
emergency and intensive care
Full quality assurance
system
EC type-examination
EC verification
Production quality
Annex II
Annex III
Annex IV
Annex V
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
210 / 301
assurance
Product quality assurance
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0104 - Non-active medical devices with
measuring function
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0105 - Non-active ophthalmologic devices
Full quality assurance
system
EC type-examination
Annex II
Annex III
Annex IV
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
211 / 301
EC verification
Production quality
assurance
Product quality assurance
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0106 - Non-active instruments
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0107 - Contraceptive medical devices
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
Annex III
Annex IV
Annex II
Annex V
Annex VI
Annex III. and IV. designation
excluding materials of desinfecting,
cleaning and rinsing . For Annex
II., V., VI. there are no limitations.
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
212 / 301
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0109 - Non-active devices for in vitro fertilisation
(IVF) and assisted reproductive technologies (ART)
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
EC type-examination
EC verification
Annex III
Annex IV
*MD 0400 - Non-active dental devices and accessories
- *MD 0402 - Dental materials
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
*MD 0400 - Non-active dental devices and accessories
- *MD 0403 - Dental implants
EC type-examination
EC verification
Annex III
Annex IV
*MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
Full quality assurance
system
EC type-examination
EC verification
Annex II
Annex III
Annex IV
Annex V
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
213 / 301
Production quality
assurance
Product quality assurance
Annex VI
*MD 1100 - General active medical devices
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1103 - Devices for stimulation or inhibition
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1104 - Active surgical devices
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1105 - Active ophthalmologic devices
Full quality assurance
system
Annex II
Annex III
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
214 / 301
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex IV
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1106 - Active dental devices
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1107 - Active devices for disinfection and
sterilisation
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1108 - Active rehabilitation devices and active
prostheses
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
215 / 301
*MD 1100 - General active medical devices
- *MD 1109 - Active devices for patient positioning and
transport
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1110 - Active devices for in vitro fertilisation
(IVF) and assisted reproductive therapy (ART)
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1111 - Software
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
*MD 0200 - Non-active implants
- *MD 0201 - Non-active cardiovascular implants
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
Annex III
Annex IV
Annex II
Annex V
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
216 / 301
EC declaration of
conformity (production
quality assurance)
*MD 0200 - Non-active implants
- *MD 0202 - Non-active orthopaedic implants
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
Annex III
Annex IV
Annex II
Annex V
*MD 0200 - Non-active implants
- *MD 0203 - Non-active functional implants
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
Annex III
Annex IV
Annex II
Annex V
*MD 0200 - Non-active implants
- *MD 0204 - Non-active soft tissue implants
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
Annex II
Annex V
*MD 0300 - Devices for wound care
- *MD 0303 - Other medical devices for wound care
EC declaration of
conformity (full quality
assurance system)
Annex II
Annex V
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
217 / 301
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex VI
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
*MD 0300 - Devices for wound care
- *MD 0302 - Suture material and clamps
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1112 - Medical gas supply systems and parts
thereof
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
Annex III
Annex IV
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
218 / 301
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
Designation excludes products
under the scope MD 0201
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
Designation excludes products
related 2003/32/EC BSE/TSE field.
Designation includes Annex 2 and
5.
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by softwareELEKTROTECHNICKÝ ZKUŠEBNÍ ÚSTAV,s.p.Pod Lisem 129171 02 PRAHA 71 - TrojaCzech Republic
1014 *MD 0100 - General non-active, non-implantable
medical devices
- *MD 0101 - Non-active devices for anaesthesia,
emergency and intensive care
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
- *MD 0104 - Non-active medical devices with
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
219 / 301
measuring function
- *MD 0105 - Non-active ophthalmologic devices
- *MD 0106 - Non-active instruments
- *MD 0107 - Contraceptive medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
- *MD 0109 - Non-active devices for in vitro fertilisation
(IVF) and assisted reproductive technologies (ART)
*MD 0200 - Non-active implants
- *MD 0201 - Non-active cardiovascular implants
- *MD 0202 - Non-active orthopaedic implants
- *MD 0203 - Non-active functional implants
- *MD 0204 - Non-active soft tissue implants
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
- *MD 0302 - Suture material and clamps
- *MD 0303 - Other medical devices for wound care
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
- *MD 0402 - Dental materials
- *MD 0403 - Dental implants
*MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
- *MD 1102 - Respiratory devices, devices including
Full quality assurance
system
EC type-examination
EC verification
Annex II
Annex III
Annex IV
Annex V
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
220 / 301
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
- *MD 1103 - Devices for stimulation or inhibition
- *MD 1104 - Active surgical devices
- *MD 1105 - Active ophthalmologic devices
- *MD 1106 - Active dental devices
- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1108 - Active rehabilitation devices and active
prostheses
- *MD 1109 - Active devices for patient positioning and
transport
- *MD 1110 - Active devices for in vitro fertilisation
(IVF) and assisted reproductive therapy (ART)
- *MD 1111 - Software
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
- *MD 1302 - Monitoring devices of vital physiological
parameters
*MD 1400 - Devices for radiation therapy and thermo
therapy
Production quality
assurance
Product quality assurance
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
221 / 301
- *MD 1401 - Devices utilising ionizing radiation
- *MD 1402 - Devices utilising non-ionizing radiation
- *MD 1403 - Devices for hyperthermia / hypothermia
- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
except application of Commission
Regulation 722/2012
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbedINSTITUT PRO TESTOVÁNI A CERTIFIKACI,a. s.T. Bati 299Louky, 76302 ZLINCzech Republic
1023 *MD 0100 - General non-active, non-implantable
medical devices
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
- *MD 0101 - Non-active devices for anaesthesia,
emergency and intensive care
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
Full quality assurance
system
EC verification
Production quality
Annex II
Annex IV
Annex V
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
222 / 301
- *MD 0104 - Non-active medical devices with
measuring function
assurance
Product quality assurance
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0105 - Non-active ophthalmologic devices
- *MD 0106 - Non-active instruments
- *MD 0107 - Contraceptive medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
- *MD 0109 - Non-active devices for in vitro fertilisation
(IVF) and assisted reproductive technologies (ART)
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
*MD 0200 - Non-active implants
- *MD 0201 - Non-active cardiovascular implants
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Annex II
Annex III
Annex IV
Annex V
*MD 0200 - Non-active implants
- *MD 0202 - Non-active orthopaedic implants
- *MD 0203 - Non-active functional implants
- *MD 0204 - Non-active soft tissue implants
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
- *MD 0302 - Suture material and clamps
- *MD 0303 - Other medical devices for wound care
*MD 0400 - Non-active dental devices and accessories
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
223 / 301
- *MD 0401 - Non-active dental equipment and
instruments
- *MD 0402 - Dental materials
- *MD 0403 - Dental implants
*MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
- *MD 1103 - Devices for stimulation or inhibition
- *MD 1104 - Active surgical devices
- *MD 1105 - Active ophthalmologic devices
- *MD 1106 - Active dental devices
- *MD 1107 - Active devices for disinfection and
sterilisation
*MD 1100 - General active medical devices
- *MD 1108 - Active rehabilitation devices and active
prostheses
- *MD 1109 - Active devices for patient positioning and
transport
Full quality assurance
system
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex IV
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1110 - Active devices for in vitro fertilisation
(IVF) and assisted reproductive therapy (ART)
- *MD 1111 - Software
Full quality assurance
system
EC type-examination
EC verification
Annex II
Annex III
Annex IV
Annex V
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
224 / 301
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
Production quality
assurance
Product quality assurance
Annex VI
*MD 1200 - Devices for imaging
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
Full quality assurance
system
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex IV
Annex V
Annex VI
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
- *MD 1302 - Monitoring devices of vital physiological
parameters
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1402 - Devices utilising non-ionizing radiation
Full quality assurance
system
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex IV
Annex V
Annex VI
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1403 - Devices for hyperthermia / hypothermia
- *MD 1404 - Devices for (extracorporal) shock-wave
Full quality assurance
system
EC type-examination
EC verification
Annex II
Annex III
Annex IV
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
225 / 301
therapy (lithotripsy) Production quality
assurance
Product quality assurance
Annex V
Annex VI
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
*MDS 7003 - Medical devices incorporating derivates of
human blood, according to Directive 2000/70/EC,
amended by Directive 2001/104/EC
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7005 - Medical devices referencing the Directive
89/686/EEC on personal protective equipment (PPE)
*MDS 7006 - Medical devices in sterile condition
*MDS 7007 - Medical devices utilising micromechanics
*MDS 7008 - Medical devices utilising nanomaterials
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbedSCHWEIZERISCHE VEREINIGUNG FÜRQUALITÄTS- UND MANAGEMENTSYSTEMEBernstrasse 1033052 ZOLLIKOFENSwitzerland
1250 *MD 0100 - General non-active, non-implantable
medical devices
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable Full quality assurance Annex II
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
226 / 301
medical devices
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
system
Production quality
assurance
Product quality assurance
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0104 - Non-active medical devices with
measuring function
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0105 - Non-active ophthalmologic devices
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0106 - Non-active instruments
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0101 - Non-active devices for anaesthesia,
Full quality assurance
system
Production quality
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
227 / 301
emergency and intensive care assurance
Product quality assurance
*MD 0200 - Non-active implants
- *MD 0202 - Non-active orthopaedic implants
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0200 - Non-active implants
- *MD 0203 - Non-active functional implants
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0200 - Non-active implants
- *MD 0204 - Non-active soft tissue implants
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0300 - Devices for wound care
- *MD 0302 - Suture material and clamps
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
228 / 301
*MD 0300 - Devices for wound care
- *MD 0303 - Other medical devices for wound care
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0400 - Non-active dental devices and accessories
- *MD 0402 - Dental materials
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0400 - Non-active dental devices and accessories
- *MD 0403 - Dental implants
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
excluding heart-lung machine
*MD 1100 - General active medical devices
- *MD 1102 - Respiratory devices, devices including
Full quality assurance
system
Annex II
Annex V
only respiratory devices
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
229 / 301
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
Production quality
assurance
Product quality assurance
Annex VI
*MD 1100 - General active medical devices
- *MD 1103 - Devices for stimulation or inhibition
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1104 - Active surgical devices
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1105 - Active ophthalmologic devices
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1106 - Active dental devices
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1107 - Active devices for disinfection and
sterilisation
Full quality assurance
system
Production quality
assurance
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
230 / 301
Product quality assurance
*MD 1100 - General active medical devices
- *MD 1108 - Active rehabilitation devices and active
prostheses
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1200 - Devices for imaging
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile conditionQS Zürich AGPostfach 6335CH-8050 ZürichSwitzerland
1254 *MD 0100 - General non-active, non-implantable
medical devices
- *MD 0101 - Non-active devices for anaesthesia,
Full quality assurance
system
Production quality
Annex II
Annex V
Single use medical products and
reusable medical instruments
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
231 / 301
emergency and intensive care assurance
Product quality assurance
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
Single use medical products and
reusable medical instruments
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
Single use medical products and
reusable medical instruments
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0104 - Non-active medical devices with
measuring function
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
Reusable medical instruments
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0105 - Non-active ophthalmologic devices
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
Single use medical products and
reusable medical instruments
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0106 - Non-active instruments
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
232 / 301
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0107 - Contraceptive medical devices
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
Single use medical products
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
Single use medical products and
reusable medical instruments
*MD 0200 - Non-active implants
- *MD 0202 - Non-active orthopaedic implants
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0200 - Non-active implants
- *MD 0203 - Non-active functional implants
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0300 - Devices for wound care
- *MD 0302 - Suture material and clamps
Full quality assurance
system
Annex II
Annex V
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
233 / 301
Production quality
assurance
Product quality assurance
Annex VI
*MD 0300 - Devices for wound care
- *MD 0303 - Other medical devices for wound care
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0400 - Non-active dental devices and accessories
- *MD 0402 - Dental materials
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 0400 - Non-active dental devices and accessories
- *MD 0403 - Dental implants
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
Full quality assurance
system
Production quality
assurance
Annex II
Annex V
Annex VI
Measuring equipment as
accessories to medical devices
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
234 / 301
Product quality assurance
*MD 1100 - General active medical devices
- *MD 1105 - Active ophthalmologic devices
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
Measuring equipment as
accessories to medical devices
*MD 1100 - General active medical devices
- *MD 1106 - Active dental devices
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1107 - Active devices for disinfection and
sterilisation
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
Measuring equipment as
accessories to medical devices
*MD 1100 - General active medical devices
- *MD 1108 - Active rehabilitation devices and active
prostheses
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1109 - Active devices for patient positioning and
transport
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1200 - Devices for imaging Full quality assurance Annex II Measuring equipment as
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
235 / 301
- *MD 1201 - Imaging devices utilising ionizing
radiation
system
Production quality
assurance
Product quality assurance
Annex V
Annex VI
accessories to medical devices
*MD 1200 - Devices for imaging
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
Measuring equipment as
accessories to medical devices
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
Measuring equipment as
accessories to medical devices
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1402 - Devices utilising non-ionizing radiation
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
Measuring equipment as
accessories to medical devices
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1403 - Devices for hyperthermia / hypothermia
Full quality assurance
system
Production quality
Annex II
Annex V
Annex VI
Measuring equipment as
accessories to medical devices
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
236 / 301
assurance
Product quality assurance
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbedEVPU a.s.Trencianska 19018 51 NOVA DUBNICASlovakia
1293 *MD 0100 - General non-active, non-implantable
medical devices
- *MD 0101 - Non-active devices for anaesthesia,
emergency and intensive care
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
- *MD 0104 - Non-active medical devices with
measuring function
- *MD 0105 - Non-active ophthalmologic devices
- *MD 0106 - Non-active instruments
- *MD 0107 - Contraceptive medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
- *MD 0109 - Non-active devices for in vitro fertilisation
(IVF) and assisted reproductive technologies (ART)
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
237 / 301
*MD 0200 - Non-active implants
- *MD 0201 - Non-active cardiovascular implants
- *MD 0202 - Non-active orthopaedic implants
- *MD 0203 - Non-active functional implants
- *MD 0204 - Non-active soft tissue implants
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Annex II
Annex III
Annex IV
Annex V
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
- *MD 0302 - Suture material and clamps
- *MD 0303 - Other medical devices for wound care
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
- *MD 0402 - Dental materials
- *MD 0403 - Dental implants
*MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
- *MD 1103 - Devices for stimulation or inhibition
- *MD 1104 - Active surgical devices
- *MD 1105 - Active ophthalmologic devices
- *MD 1106 - Active dental devices
- *MD 1107 - Active devices for disinfection and
Full quality assurance
system
EC type-examination
EC verification
Production quality
assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
238 / 301
sterilisation
- *MD 1108 - Active rehabilitation devices and active
prostheses
- *MD 1109 - Active devices for patient positioning and
transport
- *MD 1110 - Active devices for in vitro fertilisation
(IVF) and assisted reproductive therapy (ART)
- *MD 1111 - Software
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
- *MD 1302 - Monitoring devices of vital physiological
parameters
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
- *MD 1402 - Devices utilising non-ionizing radiation
- *MD 1403 - Devices for hyperthermia / hypothermia
- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
239 / 301
*MDS 7003 - Medical devices incorporating derivates of
human blood, according to Directive 2000/70/EC,
amended by Directive 2001/104/EC
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7005 - Medical devices referencing the Directive
89/686/EEC on personal protective equipment (PPE)
*MDS 7006 - Medical devices in sterile condition
*MDS 7007 - Medical devices utilising micromechanics
*MDS 7008 - Medical devices utilising nanomaterials
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbedBUREAU VERITAS ITALIA S.P.A.Via Miramare, 1520126 - MILANOItaly
1370 *MD 0100 - General non-active, non-implantable
medical devices
- *MD 0101 - Non-active devices for anaesthesia,
emergency and intensive care
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
240 / 301
EC declaration of
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0105 - Non-active ophthalmologic devices
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0106 - Non-active instruments
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
Annex II
Annex V
Annex VI
Excluding class III medical devices
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
241 / 301
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 0300 - Devices for wound care
- *MD 0302 - Suture material and clamps
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
Annex II
Annex V
Annex VI
Excluding class III medical devices
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
242 / 301
assurance)
*MD 0300 - Devices for wound care
- *MD 0303 - Other medical devices for wound care
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 0400 - Non-active dental devices and accessories
- *MD 0402 - Dental materials
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
243 / 301
*MD 0400 - Non-active dental devices and accessories
- *MD 0403 - Dental implants
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 1100 - General active medical devices
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices,
hyperbaric chambers for oxygen
therapy and medical gas pipeline
systems
*MD 1100 - General active medical devices
- *MD 1103 - Devices for stimulation or inhibition
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
244 / 301
- *MD 1104 - Active surgical devices conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1106 - Active dental devices
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 1100 - General active medical devices
- *MD 1107 - Active devices for disinfection and
sterilisation
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 1100 - General active medical devices
- *MD 1108 - Active rehabilitation devices and active
EC declaration of
conformity (full quality
Annex II
Annex V
Excluding class III medical devices
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
245 / 301
prostheses assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex VI
*MD 1100 - General active medical devices
- *MD 1111 - Software
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
EC declaration of
conformity (full quality
assurance system)
Annex II
Annex V
Annex VI
Excluding class III medical devices
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
246 / 301
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1300 - Monitoring devices
- *MD 1302 - Monitoring devices of vital physiological
parameters
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1403 - Devices for hyperthermia / hypothermia
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
Excluding class III medical devices
*MDS 7006 - Medical devices in sterile condition Excluding class III medical devicesPOLSKIE CENTRUM BADAN ICERTYFIKACJI S.A.
1434 *MD 0100 - General non-active, non-implantable EC type-examination Annex III
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
247 / 301
ul. Klobucka 23A02-699 WarszawaPoland
medical devices
- *MD 0101 - Non-active devices for anaesthesia,
emergency and intensive care
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
Annex IV
Annex II
Annex V
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
- *MD 0104 - Non-active medical devices with
measuring function
- *MD 0105 - Non-active ophthalmologic devices
- *MD 0106 - Non-active instruments
- *MD 0107 - Contraceptive medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
*MD 0200 - Non-active implants
- *MD 0201 - Non-active cardiovascular implants
- *MD 0202 - Non-active orthopaedic implants
- *MD 0203 - Non-active functional implants
- *MD 0204 - Non-active soft tissue implants
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
- *MD 0302 - Suture material and clamps
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
248 / 301
- *MD 0303 - Other medical devices for wound care
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
- *MD 0402 - Dental materials
- *MD 0403 - Dental implants
*MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
- *MD 1103 - Devices for stimulation or inhibition
- *MD 1104 - Active surgical devices
- *MD 1105 - Active ophthalmologic devices
- *MD 1106 - Active dental devices
- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1108 - Active rehabilitation devices and active
prostheses
- *MD 1109 - Active devices for patient positioning and
transport
- *MD 1111 - Software
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
- *MD 1202 - Imaging devices utilising non-ionizing
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
249 / 301
radiation
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
- *MD 1302 - Monitoring devices of vital physiological
parameters
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
- *MD 1402 - Devices utilising non-ionizing radiation
- *MD 1403 - Devices for hyperthermia / hypothermia
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
*MDS 7003 - Medical devices incorporating derivates of
human blood, according to Directive 2000/70/EC,
amended by Directive 2001/104/EC
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition
*MDS 7007 - Medical devices utilising micromechanics
*MDS 7008 - Medical devices utilising nanomaterials
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
250 / 301
SGS Belgium NVNoorderlaan 87BE-2030 AntwerpenBelgium
1639 *MD 0100 - General non-active, non-implantable
medical devices
- *MD 0101 - Non-active devices for anaesthesia,
emergency and intensive care
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
No class III medical devices.
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
No class III medical devices.
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
No class III medical devices.
*MD 0100 - General non-active, non-implantable EC declaration of Annex II No class III medical devices.
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
251 / 301
medical devices
- *MD 0104 - Non-active medical devices with
measuring function
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0105 - Non-active ophthalmologic devices
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
No class III medical devices.
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0106 - Non-active instruments
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
No class III medical devices.
*MD 0100 - General non-active, non-implantable
medical devices
EC declaration of
conformity (full quality
Annex II
Annex V
No class III medical devices.
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
252 / 301
- *MD 0107 - Contraceptive medical devices assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
No class III medical devices.
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0109 - Non-active devices for in vitro fertilisation
(IVF) and assisted reproductive technologies (ART)
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
No class III medical devices.
*MD 0200 - Non-active implants
- *MD 0201 - Non-active cardiovascular implants
EC declaration of
conformity (full quality
assurance system)
Annex II
Annex V
Annex VI
No class III medical devices.
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
253 / 301
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0200 - Non-active implants
- *MD 0202 - Non-active orthopaedic implants
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
No class III medical devices.
*MD 0200 - Non-active implants
- *MD 0203 - Non-active functional implants
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
No class III medical devices.
*MD 0200 - Non-active implants
- *MD 0204 - Non-active soft tissue implants
EC declaration of
conformity (full quality
assurance system)
EC declaration of
Annex II
Annex V
Annex VI
No class III medical devices.
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
254 / 301
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
No class III medical devices.
*MD 0300 - Devices for wound care
- *MD 0302 - Suture material and clamps
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
No class III medical devices.
*MD 0300 - Devices for wound care
- *MD 0303 - Other medical devices for wound care
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
Annex II
Annex V
Annex VI
No class III medical devices.
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
255 / 301
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
No class III medical devices.
*MD 0400 - Non-active dental devices and accessories
- *MD 0402 - Dental materials
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
No class III medical devices.
*MD 0400 - Non-active dental devices and accessories
- *MD 0403 - Dental implants
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
Annex II
Annex V
Annex VI
No class III medical devices.
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
256 / 301
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
No class III medical devices.
*MD 1100 - General active medical devices
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
No class III medical devices.
*MD 1100 - General active medical devices
- *MD 1103 - Devices for stimulation or inhibition
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
Annex II
Annex V
Annex VI
No class III medical devices.
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
257 / 301
conformity (product quality
assurance)
*MD 1100 - General active medical devices
- *MD 1104 - Active surgical devices
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
No class III medical devices.
*MD 1100 - General active medical devices
- *MD 1105 - Active ophthalmologic devices
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
No class III medical devices.
*MD 1100 - General active medical devices
- *MD 1106 - Active dental devices
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
Annex II
Annex V
Annex VI
No class III medical devices.
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
258 / 301
assurance)
*MD 1100 - General active medical devices
- *MD 1107 - Active devices for disinfection and
sterilisation
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
No class III medical devices.
*MD 1100 - General active medical devices
- *MD 1108 - Active rehabilitation devices and active
prostheses
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
No class III medical devices.
*MD 1100 - General active medical devices
- *MD 1109 - Active devices for patient positioning and
transport
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
No class III medical devices.
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
259 / 301
*MD 1100 - General active medical devices
- *MD 1110 - Active devices for in vitro fertilisation
(IVF) and assisted reproductive therapy (ART)
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
No class III medical devices.
*MD 1100 - General active medical devices
- *MD 1111 - Software
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
No class III medical devices.
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
No class III medical devices.
*MD 1200 - Devices for imaging EC declaration of Annex II No class III medical devices.
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
260 / 301
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex V
Annex VI
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
No class III medical devices.
*MD 1300 - Monitoring devices
- *MD 1302 - Monitoring devices of vital physiological
parameters
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
No class III medical devices.
*MD 1400 - Devices for radiation therapy and thermo
therapy
EC declaration of
conformity (full quality
Annex II
Annex V
No class III medical devices.
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
261 / 301
- *MD 1401 - Devices utilising ionizing radiation assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex VI
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1402 - Devices utilising non-ionizing radiation
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
No class III medical devices.
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1403 - Devices for hyperthermia / hypothermia
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
No class III medical devices.
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1404 - Devices for (extracorporal) shock-wave
EC declaration of
conformity (full quality
assurance system)
Annex II
Annex V
Annex VI
No class III medical devices.
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
262 / 301
therapy (lithotripsy) EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
No class III medical devices.
*MDS 7005 - Medical devices referencing the Directive
89/686/EEC on personal protective equipment (PPE)
No class III medical devices.
*MDS 7006 - Medical devices in sterile condition No class III medical devices.TURKISH STANDARDS INSTITUTION (TSE)Necatibey Cad. No. 112, 06100 BakanliklarAnkaraTurkey
1783 *MD 0100 - General non-active, non-implantable
medical devices
- *MD 0101 - Non-active devices for anaesthesia,
emergency and intensive care
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
EC type-examination
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex II
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
- *MD 0104 - Non-active medical devices with
measuring function
- *MD 0105 - Non-active ophthalmologic devices
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
263 / 301
- *MD 0106 - Non-active instruments conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0107 - Contraceptive medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
EC type-examination
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex II
Annex V
Annex VI
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0109 - Non-active devices for in vitro fertilisation
(IVF) and assisted reproductive technologies (ART)
*MD 0200 - Non-active implants
- *MD 0201 - Non-active cardiovascular implants
- *MD 0202 - Non-active orthopaedic implants
- *MD 0203 - Non-active functional implants
- *MD 0204 - Non-active soft tissue implants
*MD 0300 - Devices for wound care
- *MD 0303 - Other medical devices for wound care
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
- *MD 0302 - Suture material and clamps
EC type-examination
EC declaration of
conformity (full quality
assurance system)
Annex III
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
264 / 301
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
- *MD 0402 - Dental materials
- *MD 0403 - Dental implants
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
- *MD 1103 - Devices for stimulation or inhibition
- *MD 1104 - Active surgical devices
- *MD 1105 - Active ophthalmologic devices
- *MD 1106 - Active dental devices
- *MD 1107 - Active devices for disinfection and
sterilisation
EC type-examination
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
265 / 301
- *MD 1108 - Active rehabilitation devices and active
prostheses
- *MD 1109 - Active devices for patient positioning and
transport
*MD 1100 - General active medical devices
- *MD 1110 - Active devices for in vitro fertilisation
(IVF) and assisted reproductive therapy (ART)
- *MD 1111 - Software
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
- *MD 1302 - Monitoring devices of vital physiological
parameters
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
- *MD 1402 - Devices utilising non-ionizing radiation
- *MD 1403 - Devices for hyperthermia / hypothermia
- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
266 / 301
*MDS 7003 - Medical devices incorporating derivates of
human blood, according to Directive 2000/70/EC,
amended by Directive 2001/104/EC
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7005 - Medical devices referencing the Directive
89/686/EEC on personal protective equipment (PPE)
*MDS 7006 - Medical devices in sterile condition
*MDS 7007 - Medical devices utilising micromechanics
*MDS 7008 - Medical devices utilising nanomaterials
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbedDARE!! CertificationsVijzelmolenlaan 7NL-3447 GX WoerdenNetherlands
1912 *MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
EC type-examination
EC verification
Annex III
Annex IV
Limited to devices for infusion.
Limited to non sterile class Im, IIa
and IIb devices
*MD 1100 - General active medical devices
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
EC type-examination
EC verification
Annex III
Annex IV
Limited to non sterile class Im, IIa
and IIb devices
*MD 1100 - General active medical devices
- *MD 1103 - Devices for stimulation or inhibition
EC type-examination
EC verification
Annex III
Annex IV
Limited to non sterile class Im, IIa
and IIb devices
*MD 1100 - General active medical devices
- *MD 1104 - Active surgical devices
EC type-examination
EC verification
Annex III
Annex IV
Limited to non sterile class Im, IIa
and IIb devices
*MD 1100 - General active medical devices
- *MD 1108 - Active rehabilitation devices and active
EC type-examination
EC verification
Annex III
Annex IV
Limited to non sterile class Im, IIa
and IIb devices
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
267 / 301
prostheses
*MD 1100 - General active medical devices
- *MD 1109 - Active devices for patient positioning and
transport
EC type-examination
EC verification
Annex III
Annex IV
Limited to non sterile class Im, IIa
and IIb devices
*MD 1200 - Devices for imaging
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
EC type-examination
EC verification
Annex III
Annex IV
Limited to non sterile class Im, IIa
and IIb devices
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
EC type-examination
EC verification
Annex III
Annex IV
Limited to non sterile class Im, IIa
and IIb devices
*MD 1300 - Monitoring devices
- *MD 1302 - Monitoring devices of vital physiological
parameters
EC type-examination
EC verification
Annex III
Annex IV
Limited to non sterile class Im, IIa
and IIb devices
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1402 - Devices utilising non-ionizing radiation
EC type-examination
EC verification
Annex III
Annex IV
Limited to non sterile class Im, IIa
and IIb devices
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
Limited to non sterile class Im, IIa
and IIb devices
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
Limited to non sterile class Im, IIa
and IIb devicesTUV Rheinland Italia SRLVia Mattei, 320010 - Pogliano Milanese (MI)Italy
1936 *MD 0100 - General non-active, non-implantable
medical devices
- *MD 0101 - Non-active devices for anaesthesia,
emergency and intensive care
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
Annex II
Annex V
Annex VI
Excluding class III medical devices
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
268 / 301
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
- Excluding Non-active devices for
transfusion and dialysis
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0104 - Non-active medical devices with
measuring function
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
Annex IV
Annex II
Annex V
Annex VI
Excluding class III medical devices
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
269 / 301
conformity (product quality
assurance)
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0105 - Non-active ophthalmologic devices
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0106 - Non-active instruments
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0107 - Contraceptive medical devices
EC declaration of
conformity (full quality
assurance system)
Annex II Excluding class III medical devices
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
Annex II
Annex V
Annex VI
Excluding class III medical devices
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
270 / 301
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 0300 - Devices for wound care
- *MD 0302 - Suture material and clamps
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 0300 - Devices for wound care
- *MD 0303 - Other medical devices for wound care
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
271 / 301
EC declaration of
conformity (product quality
assurance)
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 0400 - Non-active dental devices and accessories
- *MD 0402 - Dental materials
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 0400 - Non-active dental devices and accessories
- *MD 0403 - Dental implants
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
Annex II
Annex V
Annex VI
Excluding class III medical devices
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
272 / 301
conformity (product quality
assurance)
*MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 1100 - General active medical devices
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Excluding class III medical devices
and hyperbaric chambers for
oxygen therapy
*MD 1100 - General active medical devices
- *MD 1103 - Devices for stimulation or inhibition
EC type-examination
EC verification
EC declaration of
Annex III
Annex IV
Annex II
Excluding class III medical devices
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
273 / 301
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex V
Annex VI
*MD 1100 - General active medical devices
- *MD 1104 - Active surgical devices
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 1100 - General active medical devices
- *MD 1105 - Active ophthalmologic devices
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
Annex IV
Annex II
Annex V
Annex VI
Excluding class III medical devices
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
274 / 301
assurance)
*MD 1100 - General active medical devices
- *MD 1106 - Active dental devices
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex IV
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 1100 - General active medical devices
- *MD 1107 - Active devices for disinfection and
sterilisation
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 1100 - General active medical devices
- *MD 1108 - Active rehabilitation devices and active
prostheses
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
Annex IV
Annex II
Annex V
Annex VI
Excluding class III medical devices
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
275 / 301
quality assurance)
EC declaration of
conformity (product quality
assurance)
*MD 1100 - General active medical devices
- *MD 1109 - Active devices for patient positioning and
transport
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex IV
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 1100 - General active medical devices
- *MD 1111 - Software
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
Annex II
Annex V
Excluding class III medical devices
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Excluding class III medical devices
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
276 / 301
EC declaration of
conformity (product quality
assurance)
*MD 1200 - Devices for imaging
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex IV
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex IV
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 1300 - Monitoring devices
- *MD 1302 - Monitoring devices of vital physiological
parameters
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
Annex III
Annex IV
Annex II
Annex V
Excluding class III medical devices
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
277 / 301
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex VI
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
EC type-examination
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1402 - Devices utilising non-ionizing radiation
EC verification
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex IV
Annex II
Annex V
Annex VI
Excluding class III medical devices
*MD 1400 - Devices for radiation therapy and thermo EC verification Annex IV Excluding class III medical devices
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
278 / 301
therapy
- *MD 1403 - Devices for hyperthermia / hypothermia
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
conformity (product quality
assurance)
Annex II
Annex V
Annex VI
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
Annex II
Annex V
Excluding class III medical devices
*MDS 7006 - Medical devices in sterile condition Excluding class III medical devicesSGS Hungária Minoségellenorzo, Kereskedelmiés Szolgáltató Kft.Sirály utca 4.H-1124 BudapestHungary
1979 Active medical devices
Non-active medical devices, except soft tissue implants,
cardio vascular implants and dental materials
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
Kiwa Meyer Belgelendirme Hizmetleri A.#.Tepeören Mevkii Ankara Asfalt# Maret Arkas#ITOSB 9. Cadde No: 15 TuzlaIstanbulTurkey
1984 *MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
*MD 1300 - Monitoring devices
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
279 / 301
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
- *MD 1302 - Monitoring devices of vital physiological
parameters
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
- *MD 1402 - Devices utilising non-ionizing radiation
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0101 - Non-active devices for anaesthesia,
emergency and intensive care
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
- *MD 0106 - Non-active instruments
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
- *MD 0109 - Non-active devices for in vitro fertilisation
(IVF) and assisted reproductive technologies (ART)
*MD 0200 - Non-active implants
- *MD 0201 - Non-active cardiovascular implants
- *MD 0202 - Non-active orthopaedic implants
- *MD 0203 - Non-active functional implants
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
- *MD 0302 - Suture material and clamps
- *MD 0303 - Other medical devices for wound care
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
280 / 301
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
- *MD 0402 - Dental materials
- *MD 0403 - Dental implants
*MD 1100 - General active medical devices
- *MD 1111 - Software
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
- *MD 1103 - Devices for stimulation or inhibition
- *MD 1104 - Active surgical devices
- *MD 1105 - Active ophthalmologic devices
- *MD 1106 - Active dental devices
- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1109 - Active devices for patient positioning and
transport
- *MD 1110 - Active devices for in vitro fertilisation
(IVF) and assisted reproductive therapy (ART)
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
- *MD 0104 - Non-active medical devices with
measuring function
- *MD 0105 - Non-active ophthalmologic devices
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
281 / 301
- *MD 0107 - Contraceptive medical devices
*MD 0200 - Non-active implants
- *MD 0204 - Non-active soft tissue implants
*MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
- *MD 1108 - Active rehabilitation devices and active
prostheses
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1403 - Devices for hyperthermia / hypothermia
- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)
conformity (product quality
assurance)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7003 - Medical devices incorporating derivates of
human blood, according to Directive 2000/70/EC,
amended by Directive 2001/104/EC
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7005 - Medical devices referencing the Directive
89/686/EEC on personal protective equipment (PPE)
*MDS 7006 - Medical devices in sterile condition
*MDS 7007 - Medical devices utilising micromechanics
*MDS 7008 - Medical devices utilising nanomaterials
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
282 / 301
absorbedAlberk QA Uluslararas# Teknik Kontrol veBelgelendirme Anonim #irketiBarbaros Mahallesi Ak Zambak Sokak A BlokKat: 19 No: 2 Ata#ehirIstanbulTurkey
2138 *MD 0300 - Devices for wound care
- *MD 0303 - Other medical devices for wound care
- *MD 0301 - Bandages and wound dressings
- *MD 0302 - Suture material and clamps
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
- *MD 0402 - Dental materials
- *MD 0403 - Dental implants
*MD 1100 - General active medical devices
- *MD 1109 - Active devices for patient positioning and
transport
- *MD 1111 - Software
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
- *MD 1103 - Devices for stimulation or inhibition
- *MD 1104 - Active surgical devices
- *MD 1105 - Active ophthalmologic devices
- *MD 1106 - Active dental devices
- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1108 - Active rehabilitation devices and active
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
Annex II
Annex V
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
283 / 301
prostheses
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
- *MD 1302 - Monitoring devices of vital physiological
parameters
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
- *MD 1402 - Devices utilising non-ionizing radiation
- *MD 1403 - Devices for hyperthermia / hypothermia
- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0101 - Non-active devices for anaesthesia,
emergency and intensive care
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
- *MD 0104 - Non-active medical devices with
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
284 / 301
measuring function
- *MD 0105 - Non-active ophthalmologic devices
- *MD 0106 - Non-active instruments
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
*MD 0200 - Non-active implants
- *MD 0203 - Non-active functional implants
- *MD 0204 - Non-active soft tissue implants
- *MD 0201 - Non-active cardiovascular implants
- *MD 0202 - Non-active orthopaedic implants
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7003 - Medical devices incorporating derivates of
human blood, according to Directive 2000/70/EC,
amended by Directive 2001/104/EC
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition
*MDS 7007 - Medical devices utilising micromechanics
*MDS 7008 - Medical devices utilising nanomaterials
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by softwareSzutest Teknik Kontrol ve BelgelendirmeHizmetleri Ticaret Limited #irketi
2195 *MD 0100 - General non-active, non-implantable Full quality assurance Annex II
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
285 / 301
Yukar# Dudullu Mahallesi Nato Yolu CaddesiÇam Sokak No: 7Ümraniye/#STANBULTurkey
medical devices
- *MD 0101 - Non-active devices for anaesthesia,
emergency and intensive care
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
- *MD 0104 - Non-active medical devices with
measuring function
- *MD 0105 - Non-active ophthalmologic devices
- *MD 0106 - Non-active instruments
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
*MD 0200 - Non-active implants
- *MD 0202 - Non-active orthopaedic implants
- *MD 0203 - Non-active functional implants
- *MD 0204 - Non-active soft tissue implants
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
- *MD 0302 - Suture material and clamps
- *MD 0303 - Other medical devices for wound care
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
- *MD 0402 - Dental materials
- *MD 0403 - Dental implants
system
Production quality
assurance
Annex V
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
286 / 301
*MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
- *MD 1103 - Devices for stimulation or inhibition
- *MD 1104 - Active surgical devices
- *MD 1105 - Active ophthalmologic devices
- *MD 1106 - Active dental devices
- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1111 - Software
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
- *MD 1302 - Monitoring devices of vital physiological
parameters
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
- *MD 1402 - Devices utilising non-ionizing radiation
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
287 / 301
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0107 - Contraceptive medical devices
- *MD 0110 - Non-active medical devices for ingestion
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
Annex II
Annex V
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition
*MDS 7007 - Medical devices utilising micromechanics
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software3EC International a.s.3EC International a.s. Hrani#ná 18 Bratislava82105 SLOVAKIABratislava 82105Slovakia
2265 *MD 0100 - General non-active, non-implantable
medical devices
- *MD 0101 - Non-active devices for anaesthesia,
emergency and intensive care
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
- *MD 0104 - Non-active medical devices with
measuring function
Full quality assurance
system
Production quality
assurance
Product quality assurance
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
288 / 301
- *MD 0105 - Non-active ophthalmologic devices
- *MD 0106 - Non-active instruments
- *MD 0107 - Contraceptive medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
- *MD 0109 - Non-active devices for in vitro fertilisation
(IVF) and assisted reproductive technologies (ART)
*MD 0200 - Non-active implants
- *MD 0201 - Non-active cardiovascular implants
- *MD 0202 - Non-active orthopaedic implants
- *MD 0203 - Non-active functional implants
- *MD 0204 - Non-active soft tissue implants
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
- *MD 0302 - Suture material and clamps
- *MD 0303 - Other medical devices for wound care
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
- *MD 0402 - Dental materials
- *MD 0403 - Dental implants
*MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
289 / 301
anaesthesia
- *MD 1103 - Devices for stimulation or inhibition
- *MD 1104 - Active surgical devices
- *MD 1105 - Active ophthalmologic devices
- *MD 1106 - Active dental devices
- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1108 - Active rehabilitation devices and active
prostheses
- *MD 1109 - Active devices for patient positioning and
transport
- *MD 1110 - Active devices for in vitro fertilisation
(IVF) and assisted reproductive therapy (ART)
- *MD 1111 - Software
*MD 1200 - Devices for imaging
- *MD 1201 - Imaging devices utilising ionizing
radiation
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
- *MD 1302 - Monitoring devices of vital physiological
parameters
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1401 - Devices utilising ionizing radiation
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
290 / 301
- *MD 1402 - Devices utilising non-ionizing radiation
- *MD 1403 - Devices for hyperthermia / hypothermia
- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition
*MDS 7007 - Medical devices utilising micromechanics
*MDS 7008 - Medical devices utilising nanomaterials
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbedDQS Polska Sp. z o.oul. Post#pu 17A02-676 WarszawaPoland
2282 *MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
Annex II
Annex V
*MD 1100 - General active medical devices
- *MD 1107 - Active devices for disinfection and
sterilisation
EC declaration of
conformity (full quality
assurance system)
EC declaration of
Annex II
Annex V
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
291 / 301
conformity (production
quality assurance)
*MD 1100 - General active medical devices
- *MD 1111 - Software
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
Annex II
Annex V
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
Annex II
Annex V
dialysers
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
Annex II
Annex V
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0104 - Non-active medical devices with
measuring function
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
Annex II
Annex V
*MD 0100 - General non-active, non-implantable
medical devices
EC declaration of
conformity (full quality
Annex II
Annex V
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
292 / 301
- *MD 0106 - Non-active instruments assurance system)
EC declaration of
conformity (production
quality assurance)
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0107 - Contraceptive medical devices
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
Annex II
Annex V
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
Annex II
Annex V
*MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
Annex II
Annex V
*MD 0300 - Devices for wound care
- *MD 0302 - Suture material and clamps
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
Annex II
Annex V
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
293 / 301
*MD 0300 - Devices for wound care
- *MD 0303 - Other medical devices for wound care
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
Annex II
Annex V
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
Annex II
Annex V
*MD 0400 - Non-active dental devices and accessories
- *MD 0402 - Dental materials
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
Annex II
Annex V
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0110 - Non-active medical devices for ingestion
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
Annex II
Annex V
*MD 0200 - Non-active implants
- *MD 0202 - Non-active orthopaedic implants
EC declaration of
conformity (full quality
assurance system)
EC declaration of
Annex II
Annex V
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
294 / 301
conformity (production
quality assurance)
*MD 0400 - Non-active dental devices and accessories
- *MD 0403 - Dental implants
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
Annex II
Annex V
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal
origin, including Regulation 722/2012 (Directive
2003/32/EC up to 28.08.2013)
*MDS 7003 - Medical devices incorporating derivates of
human blood, according to Directive 2000/70/EC,
amended by Directive 2001/104/EC
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition
*MDS 7007 - Medical devices utilising micromechanics
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by softwareUDEM Uluslararasi Belgelendirme DenetimEgitim Merkezi Sanayi ve Ticaret Limited SirketiMutlukent Mahallesi 2073 Sokak No:10Umitkoy-CANKAYAAnkaraTurkey
2292 *MD 0300 - Devices for wound care
- *MD 0301 - Bandages and wound dressings
- *MD 0302 - Suture material and clamps
- *MD 0303 - Other medical devices for wound care
*MD 0100 - General non-active, non-implantable
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
Annex II
Annex V
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
295 / 301
medical devices
- *MD 0101 - Non-active devices for anaesthesia,
emergency and intensive care
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
- *MD 0104 - Non-active medical devices with
measuring function
- *MD 0105 - Non-active ophthalmologic devices
- *MD 0106 - Non-active instruments
- *MD 0107 - Contraceptive medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
- *MD 0109 - Non-active devices for in vitro fertilisation
(IVF) and assisted reproductive technologies (ART)
*MD 0200 - Non-active implants
- *MD 0203 - Non-active functional implants
- *MD 0204 - Non-active soft tissue implants
- *MD 0201 - Non-active cardiovascular implants
- *MD 0202 - Non-active orthopaedic implants
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
- *MD 0402 - Dental materials
- *MD 0403 - Dental implants
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
296 / 301
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0110 - Non-active medical devices for ingestion
*MD 1100 - General active medical devices
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
- *MD 1104 - Active surgical devices
- *MD 1105 - Active ophthalmologic devices
- *MD 1106 - Active dental devices
- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1108 - Active rehabilitation devices and active
prostheses
- *MD 1109 - Active devices for patient positioning and
transport
- *MD 1110 - Active devices for in vitro fertilisation
(IVF) and assisted reproductive therapy (ART)
- *MD 1111 - Software
- *MD 1112 - Medical gas supply systems and parts
thereof
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
*MD 1400 - Devices for radiation therapy and thermo
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
297 / 301
therapy
- *MD 1403 - Devices for hyperthermia / hypothermia
- *MD 1404 - Devices for (extracorporal) shock-wave
therapy (lithotripsy)
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition Including aseptic processing,
ethylene oxide gas sterilisation
(EOG), low temperature steam and
formaldehyde sterilisation, moist
heat sterilisation, radiation
sterilisation (gamma, x-ray,
electron beam), others (need to be
specified)
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by softwareCE Certiso Orvos- és KórháztechnikaiEllen#rz# és Tanúsító Kft.Gyár u. 2.BudaörsHungary
2409 *MD 1200 - Devices for imaging
- *MD 1202 - Imaging devices utilising non-ionizing
radiation
*MD 1300 - Monitoring devices
- *MD 1301 - Monitoring devices of non-vital
physiological parameters
- *MD 1302 - Monitoring devices of vital physiological
EC declaration of
conformity (full quality
assurance system)
EC declaration of
conformity (production
quality assurance)
EC declaration of
Annex II
Annex V
Annex VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
298 / 301
parameters
*MD 1400 - Devices for radiation therapy and thermo
therapy
- *MD 1402 - Devices utilising non-ionizing radiation
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0101 - Non-active devices for anaesthesia,
emergency and intensive care
- *MD 0102 - Non-active devices for injection, infusion,
transfusion and dialysis
- *MD 0103 - Non-active orthopaedic and rehabilitation
devices
- *MD 0104 - Non-active medical devices with
measuring function
- *MD 0105 - Non-active ophthalmologic devices
- *MD 0106 - Non-active instruments
- *MD 0107 - Contraceptive medical devices
- *MD 0108 - Non-active medical devices for
disinfecting, cleaning, rinsing
- *MD 0109 - Non-active devices for in vitro fertilisation
(IVF) and assisted reproductive technologies (ART)
*MD 0200 - Non-active implants
- *MD 0201 - Non-active cardiovascular implants
- *MD 0202 - Non-active orthopaedic implants
- *MD 0203 - Non-active functional implants
- *MD 0204 - Non-active soft tissue implants
*MD 0300 - Devices for wound care
conformity (product quality
assurance)
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
299 / 301
- *MD 0301 - Bandages and wound dressings
- *MD 0302 - Suture material and clamps
- *MD 0303 - Other medical devices for wound care
*MD 0400 - Non-active dental devices and accessories
- *MD 0401 - Non-active dental equipment and
instruments
- *MD 0402 - Dental materials
- *MD 0403 - Dental implants
*MD 1100 - General active medical devices
- *MD 1107 - Active devices for disinfection and
sterilisation
- *MD 1108 - Active rehabilitation devices and active
prostheses
- *MD 1111 - Software
- *MD 1101 - Devices for extra-corporal circulation,
infusion and haemopheresis
- *MD 1102 - Respiratory devices, devices including
hyperbaric chambers for oxygen therapy, inhalation
anaesthesia
- *MD 1103 - Devices for stimulation or inhibition
- *MD 1104 - Active surgical devices
- *MD 1105 - Active ophthalmologic devices
- *MD 1106 - Active dental devices
*MD 0100 - General non-active, non-implantable
medical devices
- *MD 0110 - Non-active medical devices for ingestion
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
300 / 301
*MDS 7001 - Medical devices incorporating medicinal
substances, according to Directive 2001/83/EC
regarding Annex II, V, VI
*MDS 7004 - Medical devices referencing the Directive
2006/42/EC on machinery
regarding Annex II, V, VI
*MDS 7006 - Medical devices in sterile condition regarding Annex II, V, VI
*MDS 7009 - Medical devices utilising biological active
coatings and/or materials or being wholly or mainly
absorbed
regarding Annex II, V, VI
*MDS 7010 - Medical devices incorporating software
/utilising software /controlled by software
regarding Annex II, V, VI
Creation Date : 25/02/2016
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices
Name and address of the notifiedbodies
ID Responsible for the following products/Horizontal technical competence
Responsible for thefollowing procedures
or modules
Annexes orarticles of the
directives
Limitations (English only)
301 / 301