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EC Certification
IntertekPRODUCTION QUALITY ASSURANCE
Directive 93/42/EEC for Medical Devices, Annex V
We hereby declare that an examination of the under mentioned
production quality assurance system - restricted to theaspects of
manufacture concerned with securing and maintaining sterile
conditions - has been carried out following therequirements of the
UK national legislation to which the undersigned is subjected,
transposing Annex V of the Directive93/42/EEC on medical devices.
We certify that the production quality system conforms with the
relevant provisions ofthe aforementioned legislation, and the
result entitles the organization to use the CE 0473 marking on
those productslisted below.
MEDASIL (SURGICAL) LIMITED
Medasil House, Hunslet Road, Leeds LS10 1AU
Sterile single use medical devices for ear, nose, and throat
surgery, surgical procedures and catheterisation - grommets,
drains,catheters, tubes and tubing, buttons, bobbins, tissue
expanders, HPC filters, dressings and retractors.
See attached schedule
Certificate Number:Initial Certification Date:Certificate
Effective Date:Certificate Expiry Date:
071-01 CE02 February 199602 February 201601 August 2016
Brian JohnsonAMTAC Certification Services Limited, Milton
Keynes, UK
This certificate is the property of AMTAC Certification Services
Ltd
In the issuance of this certificate, Intertek assumes no
liability to any party other than to the Client, and then only in
accordance IMth the agreed upon CertificationAgreement This
certificate's validity is subject to the organization maintaining
their system in accordance ~th Intertek's requirements for systems
certification. Validitymay be confirmed via email
[email protected] or by scanning the code to
the right with a smartphone.This Certificate is for the exdusive
use of AMTAC's client and is provided pursuant to the agreement
between AMTAC and its Client AMTAC's responsibility and liability
are limited to the terms andconditions of the agreement AMTAC
assumes no liability to any party, other than to the Client in
accordance with the agreement, for any loss, expense or damage
occasioned by the use of thisCertificate. Only the Client is
authorized to permit copying or distribution of this Certrticate.
Any use of the AMTAC name or one of its marks for the sale or
advertisement of the tested material,product or service must first
be approved in \Miting by AMTAC.
The certificate remains the property of Intertek, to whom it
must be returned upon request.
The certification is subject to the organization maintaining
their system in compliance 'Nith the regulations stated in this
certificate, allowing regular assessments and following the
contractedrequirements of the Notified BOdy.AMTAC Certification
Services Limited is a Notified Body according to Directive
93/42/EEC for medical devices, with identification number0473.
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PRODUCT SCHEDULE FOR CERTIFICATE 071-01 CEMEDASIL (SURGICAL)
LIMITED
MS-002 AIRWAY INSERTS
MS-019 LASER EYE GUARD
MS-035 ZOELLNER SUCKER TIP
MS-041 LASER BITE GUARD
MS-050 ATRAUMATlC FORCEPS SLEEVE
MS-054 EXTERNAL NASAL SPLINT
MS-058 MEDASIL NASAL AND TONSIL SNARES
MS-061 VINCENT STAINLESS STEEL LASER EYE SHIELD
MS-062 VINCENT STAINLESS STEEL APPLICATOR
MS 064 CAUTERY TIP CLEANER
MS-009 SILICONE BITE GUARDS
MS-011 GAG COVERS ADULT CHILD AND MINOR
MS-012 NASAL SPLINTS PLAIN
MS-013 NASAL SPLINTS RIBBED
MS-014 NASAL SPLINTS TUBED
MS-039 MEDISWELL AURAL WICK
MS-049 MEDISWELL NASAL TAMPON
MS-063 MEDASIL PRESSURE PAD
Page 1 of1
Initial Certification Date: 02 February 1996Certificate
Effective Date: 02 February 2016
~ Brian Johnson - Authorized Signatory
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PRODUCT SCHEDULE FOR CERTIFICATE 071-01 A CEMEDASIL (SURGICAL)
LTO
IntertekMS-003 SILICONE SHEPARD GROMMET
MS-004 SILICONE PERFORATED DRAIN
MS-005 NASO MAXilLARY BAllOON CATHETERS
MS-OO? SILICONE DONALDSON GROMMET
MS-008 SILICONE T TUBES
MS-015 SILICONE PENTAGON DRAIN/MINI PENTAGON DRAIN AND
TUBING
MS-016 SILICONE LARYNGECTOMY TUBE SHAH DESIGN
MS-020 SEPTAL BUnON, TRANSLUCENT OR RADIO OPAQUE
MS-022 MUL TITUBLAR DRAIN
MS-02S SILICONE WING GROMMET
MS-026 POl YPROPYlENE AURAL GROMMET
MS-02? TEFlON SHAH GROMMET (WIRED)
MS-028 TEFLON SHAH GROMMET (UNWIRED)
MS-029 TEFLON COLLAR SUnON
MS-030 TEFLON REUTER BOBBIN
MS-031 TEFLON FLANGED VENT TUBE
MS-032 TEFLON SHEPARD GROMMET (UNWIRED)
MS-033 TEFLON SHEPARD GROMMET (WIRED)
MS-034 SILICONE FLANGED VENT TUBE
MS-40 DERMAGAIN TISSUE EXPANDERS
MS-04S MINI SUCTION DRAINAGE SYSTEM
MS-048 SILICONE FOLEY CATHETER
MS-OS6 SILICONE, FREE FLOW DRAIN / TUBING
MS-OS? SILICONE RIBBON DRAIN, RADIO OPAQUE
MS-060 PANCREATIC DRAIN
MS-06S HUMISTOM STOMA BUTTON AND HPC FILTER DEVICE
MS-06? MEDASIL SILICONE SILASTIC SHEET, TRANSIENT DRESSING
MS-021 SILICONE COLOUR CODED NERVE VESSEL RETRACTORS
MS-023 SILICONE TUBING
MS-04? CLEAR SILICONE N.Y.R.
MS-046 EXTENDED STOMA BUTTON
MS-010 SILICONE STOMA BUTTONS
Page 1 011
Initial Certification Date: 02 February 1996Certificate
Effective Date: 02 February 2016
~ Brian Johnson - Authorized Signatory
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EC Certification
IntertekFULL QUALITY ASSURANCE SYSTEM
Directive 93/42/EEC for Medical Devices, Annex 11 excluding
(4)
We hereby declare that an examination of the under mentioned
full quality assurance system has been carried outfollowing the
requirements of the UK national legislation to which the
undersigned is subjected, transposing Annex 11(with the exemption
of section 4) of the Directive 93/42/EEC on medical devices. We
certify that the full qualityassurance system conforms with the
relevant provisions of the aforementioned directive, and the result
entitles theorganization to use the CE 0473 marking on those
products listed below.
MEOASIL (SURGICAL) LTO
Medasil House, Hunslet Road, Leeds,LS10 1AU, England
Sterile single use medical devices for ear, nose, and throat
surgery, surgical procedures and catheterisation - grommets,
drains, catheters,tubes and tubing, buttons, bobbins, tissue
expanders, HPC filters, dressings and retractors
As per the attached Schedule
Certificate Number:Initial Certification Date:Certificate
Effective Date:Certificate Expiry Date:
071-01 ACE02 February 199602 February 201601 August 2016
Brian JohnsonAMTAC Certification Services Limited, Milton
Keynes, UK
This certificate is the property of AMTAC Certification Services
Ltd It: ~[!) .• :In the issuance of this certificate, Intertek
assumes no liability to any party other than to the Client, and
then only in accordance with the agreed upon CertificationAgreement
This cenificate's validity is subject to the organization
maintaining their system in accordance with Intertek's requirements
for systems certification. Validitymay be confinned via email
[email protected] or by scanning the code to
the right Yt'ith a smartphone.This Certificate is for the exclusive
use of AMTAC's client and is provided pursuant to the agreement
between AMTAC and its Client AMI AC's responsibility and liability
are limited to the terms andconditions of the agreement AMT AC
assumes no liability to any party, other than to the Client in
accordance 'lNith the agreement, for any loss, expense or damage
occasioned by the use of thisCertificate. Only the Client is
authorized to permit copying or distribution of this Certificate.
Any use of the AMTAC name or one of its marks for the sale or
advertisement of the tested material,product or service must first
be approved in writing by AMTAC.
The certificate remains the property of Intertek, to whom it
must be retumed upon request.
The certification is subject to the organization maintaining
their system in compliance v-.1ththe regulations stated in this
certificate, allov-.1ngregular assessments and foUov-.1ngthe
contractedrequirements of the Notified Body.AMTAC Certification
Services Limited is a Notified Body according to Directive
93/42/EEC for medical devices, with identification number 0473.
