EC Certificate - AMSamsltd.com/wp-content/uploads/2019/07/EC-Certificate.pdfAdvanced MedTech...
Transcript of EC Certificate - AMSamsltd.com/wp-content/uploads/2019/07/EC-Certificate.pdfAdvanced MedTech...
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.
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
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:
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*
Non Absorbable Surgical Suture U.S.P.
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
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
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
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
Certif icate No.: Project No.: Valid Until:
14074-2019-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:
Sterile & Non-Sterile Surgical Sutures with and without needles
Manufactured by:
Advanced MedTech Solutions Pvt. Ltd. P-21-22, 25-26, 34-35, GIDC Manjusar, Tal-Savli, Dist-Vadodara, Gujarat – 391775, INDIA
Has been assessed with respect to:
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.
Further details of the product(s) and conditions for certification are given overleaf.
EC Design Examination Certificate
Certif icate No.: Project No.: Valid Until:
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:
Revision Description Issue Date
0.0 Original Certificate 14-June-2019
1.0 Editorial Changes 02-July-2019
Products covered by this Certificate:
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.
EC Design Examination Certificate
Certif icate No.: Project No.: Valid Until:
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.
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 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.
Conformity declaration and marking of product
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
EC Certificate Full Quality Assurance System
Certif icate No.: Project No.: Valid Until:
14822-2019-CE-IND-NA-PS
PRJC-584672-2018-PRC-IND 27 May 2024
Place and Date:
PROD 021
Notified Body No.: 2460
For:
Høvik, 17 June 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
excluding section 4 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.
EC Certificate Full Quality Assurance System
Certif icate No.: Project No.: Valid Until:
14822-2019-CE-IND-NA-PS 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:
Revision Description Issue Date
Original Certificate 14-06-2019
Products covered by this Certificate:
Product Description Product Name Class
Non Absorbable Surgical Suture U.S.P.
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
EC Certificate Full Quality Assurance System
Certif icate No.: Project No.: Valid Until:
14822-2019-CE-IND-NA-PS 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
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