EC Certificate - AMSamsltd.com/wp-content/uploads/2019/07/EC-Certificate.pdfAdvanced MedTech Solutions Pvt. Ltd. P-21-22, 25-26, 34-35, GIDC Manjusar, Tal-Savli, Dist-Vadodara, Gujarat

EC Certificate Full Quality Assurance System

Certif icate No.: Project No.: Valid Until:

14073-2019-CE-IND-NA-PS Rev 1.0 PRJC-584672-2018-PRC-IND 27 May 2024

Place and Date:

PROD 021

Notified Body No.: 2460

For:

Høvik, 02 July 2019 DNV GL PRESAFE AS

Cathrine Wisbech

The Certificate has been digitally signed.

See www.presafe.com/digital_signatur es for more info

Notice: The Certificate is subject to terms and conditions as set out in the Certification Agreement. Failure to comply may render this Certificate invalid.

MSD-CO-078 Rev 2.0 DNV GL PRESAFE AS - Veritasv eien 3, N-1363 Høv ik, Norway - Registered Enterprise No: NO 997 067 401 MVA Page 1 of 3

This is to certify that the quality system of:

Advanced MedTech Solutions Pvt. Ltd. P-21-22, 25-26, 34-35, GIDC Manjusar, Tal-Savli, Dist-Vadodara, Gujarat – 391775, INDIA

For design, production and final product inspection/testing of:

Sterile & Non-Sterile Surgical Sutures with and without needles

Has been assessed with respect to:

The conformity assessment procedure described in Annex II of

Council Directive 93/42/EEC on Medical Devices, as amended and found to comply.

Further details of the product(s) and conditions for certification are given overleaf.





Jurisdiction

Application of Council Directive 93/42/EEC of 14 June 1993, adopted as “Forskrift om

Medisinsk Utstyr” by the Norwegian Ministry of Health and Care Services. Certificate history:

Revision Description Issue Date

0.0 Original Certificate 14-06-2019

1.0 Editorial Changes 02-07-2019

Products covered by this Certificate:

Product Description Product Name Class

Absorbable Surgical Suture U.S.P. (Synthetic)

Braided Coated Polyglactin 910 Violet & Undyed Sterilized Surgical Needled Suture

ADVACRYL III*

Absorbable Surgical Suture (Synthetic)

Monofilament Poliglecaprone 25 Violet & Undyed Sterilized Surgical Needled Suture

ADVAMRYL III*

Absorbable Surgical Suture (Synthetic)

Monofilament Polydioxanone Violet Sterilized Surgical Needled Suture

ADVAPD III*

Non Absorbable Surgical Suture U.S.P.

Monofilament Polypropylene Blue Sterilized Surgical Needled Suture

ADVALENE III*


Braided Silk Black Sterilized Surgical Needled Suture or Without Needle

ADVASYL III*

* Design assessment is covered by a separate EC-Design Examination Certificate No.: 14074- 2019-CE-IND-NA-PS Rev 1.0

Sites covered by this certificate

Site Name Address

Advanced MedTech Solutions

Pvt. Ltd.

P-21-22, 25-26, 34-35, GIDC Manjusar, Tal-Savli, Dist-

Vadodara, Gujarat – 391775, INDIA





EU Representative

Obelis SA,

Bd, General Wahis 53, 1030, Brussels, Belgium

Terms and conditions

The certificate is subject to the following terms and conditions: Any producer (see 2001/95/EC for a precise definition) is liable for damage caused by a

defect in his product(s), in accordance with directive 85/374/EEC, as amended, concerning liability of defective products.

The certificate is only valid for the products and/or manufacturing premises listed above.

The Manufacturer shall fulfil the obligations arising out of the quality system as approved and uphold it so that it remains adequate and efficient.

The Manufacturer shall inform Presafe of any intended updating of the quality system and Presafe will assess the changes and decide if the certificate remains valid.

Periodical audits will be held, in order to verify that the Manufacturer maintains and

applies the quality system. Presafe reserves the right, on a spot basis or based on suspicion, to pay unannounced visits.

The following may render this Certificate invalid: Changes in the quality system affecting production.

Periodical audits not held within the allowed time window.

Conformity declaration and marking of product

When meeting with the terms and conditions above, the producer may draw up an EC declaration of conformity and legally affix the CE mark followed by the Notified Body

identification number of Presafe.

End of Certificate

EC Design Examination Certificate



Place and Date:

PROD 021


For:

Høvik, 02 July 2019 DNV GL PRESAFE AS

Cathrine Wisbech





This is to certify that:


Manufactured by:



Examination of the design of the product as described in Annex II

section 4 of Council Directive 93/42/EEC on Medical Devices, as amended

and found to comply.




14074-2019-CE-IND-NA-PS Rev. 1.0 PRJC-584672-2018-PRC-IND 27 May 2024

MSD-CO-078 Rev. 2.0 DNV GL PRESAFE AS - Veritasv eien 3, N-1363 Høv ik, Norway - Registered Enterprise No: NO 997 067 401 MVA Page 2 of 3

Jurisdiction

Application of Council Directive 93/42/EEC of 14 June 1993, adopted as “Forskrift om Medisinsk Utstyr” by the Norwegian Ministry of Health and Care Services.

Certificate history:


0.0 Original Certificate 14-June-2019

1.0 Editorial Changes 02-July-2019


Type of medical device and identification no.:

ADVACRYL ADVAMRYL ADVAPD

ADVALENE ADVASYL

Medical Device Class:

III

GMDN code:

17471 16584 16584

13909 13910

Short description of the Medical Device:

ADVACRYL / Braided Coated Polyglactin 910 (Absorbable) Surgical Sutures are either dyed with D and C Violet #2 (Colour Index No. 60725/Solvent Violet 13) or undyed. These sutures are

indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, peripheral nerve anastomosis & microsurgery for vessels less than 2mm diameter, but

not for cardiovascular tissues. Ethylene Oxide sterilized. ADVAMRYL / Monofilament Poliglecaprone 25 (Absorbable) Surgical Sutures are either dyed with

D and C Violet #2 (Colour Index No. 60725/Solvent Violet 13) or undyed. These sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in ophthalmic

surgery, microsurgery, cardiovascular & neurological tissues. Ethylene Oxide sterilized. ADVAPD / Monofilament Polydioxanone (Absorbable) Surgical Sutures are dyed with D and C

Violet #2 (Colour Index No. 60725/Solvent Violet 13). These sutures are indicated for use in general soft tissue approximation, including use in ophthalmic surgery and paediatric

cardiovascular tissue where growth is expected to occur but not for use in adult cardiovascular tissues, peripheral nerve anastomosis & microsurgery. Ethylene Oxide sterilized.



14074-2019-CE-IND-NA-PS Rev. 1.0 PRJC-584672-2018-PRC-IND 27 May 2024

MSD-CO-078 Rev. 2.0 DNV GL PRESAFE AS - Veritasv eien 3, N-1363 Høv ik, Norway - Registered Enterprise No: NO 997 067 401 MVA Page 3 of 3

ADVALENE / Monofilament Polypropylene (Non-Absorbable) Surgical Sutures are dyed with

Phthalocyanine blue, Colour Index No. P.B. 15:3 / 74160. These sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, peripheral

nerve anastomosis, cardiovascular and neurological procedures. Ethylene Oxide sterilized. ADVASYL / Braided Silk (Non-Absorbable) Surgical Sutures are Coated with wax, dyed in

logwood black with Hematein HCK (Colour Index No. 75290). These sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic and neurological

procedures. Gamma sterilized.


The certificate is subject to the following terms and conditions:

Any producer (see 2001/95/EC for a precise definition) is liable for damage caused by a defect in his product(s), in accordance with directive 85/374/EEC, as amended,

concerning liability of defective products.

The certificate is only valid for the products and/or manufacturing premises listed above.

The Manufacturer shall inform Presafe of any intended change of the products detailed above and Presafe will assess the changes and decide if the certificate remains valid.

The following may render this Certificate invalid:

Changes in the design of the products to which this Certificate refers.

Changes in requirements of the scheme to which this Certificate refers.


This Certificate must be accompanied with a valid EC Certificate Full Quality Assurance System.

When meeting with the terms and conditions above, the producer may draw up an EC

declaration of conformity and legally affix the CE mark followed by the Notified Body identification number of Presafe.

End of Certificate



14822-2019-CE-IND-NA-PS

PRJC-584672-2018-PRC-IND 27 May 2024

Place and Date:

PROD 021


For:

Høvik, 17 June 2019 DNV GL PRESAFE AS

Cathrine Wisbech





This is to certify that the quality system of:


For design, production and final product inspection/testing of:



The conformity assessment procedure described in Annex II

excluding section 4 of Council Directive 93/42/EEC on Medical Devices, as amended

and found to comply.




14822-2019-CE-IND-NA-PS PRJC-584672-2018-PRC-IND 27 May 2024


Jurisdiction

Application of Council Directive 93/42/EEC of 14 June 1993, adopted as “Forskrift om

Medisinsk Utstyr” by the Norwegian Ministry of Health and Care Services.

Certificate history:


Original Certificate 14-06-2019


Product Description Product Name Class


Monofilament Polyamide Black

Sterilized Surgical Needled Suture or Without Needle

ADVALON IIb

The complete list of devices is filed with the Notified Body

Sites covered by this certificate

Site Name Address

Advanced MedTech Solutions

Pvt. Ltd

P-21-22, 25-26, 34-35, GIDC Manjusar, Tal-Savli, Dist-

Vadodara, Gujarat – 391775, INDIA

EU Representative

Obelis SA,

Bd, General Wahis 53, 1030, Brussels, Belgium



14822-2019-CE-IND-NA-PS PRJC-584672-2018-PRC-IND 27 May 2024



The certificate is subject to the following terms and conditions:

Any producer (see 2001/95/EC for a precise definition) is liable for damage caused by a defect in his product(s), in accordance with directive 85/374/EEC, as amended, concerning liability of defective products.

The certificate is only valid for the products and/or manufacturing premises listed above. The Manufacturer shall fulfil the obligations arising out of the quality system as approved

and uphold it so that it remains adequate and efficient. The Manufacturer shall inform Presafe of any intended updating of the quality system

and Presafe will assess the changes and decide if the certificate remains valid.

Periodical audits will be held, in order to verify that the Manufacturer maintains and applies the quality system. Presafe reserves the right, on a spot basis or based on

suspicion, to pay unannounced visits.

The following may render this Certificate invalid:

Changes in the quality system affecting production. Periodical audits not held within the allowed time window.


When meeting with the terms and conditions above, the producer may draw up an EC

declaration of conformity and legally affix the CE mark followed by the Notified Body identification number of Presafe.

End of Certificate

Documents

EC Certificate - AMSamsltd.com/wp-content/uploads/2019/07/EC-Certificate.pdfAdvanced MedTech Solutions Pvt. Ltd. P-21-22, 25-26, 34-35, GIDC Manjusar, Tal-Savli, Dist-Vadodara, Gujarat