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EC Certificate - Metallic Stents

EC Certificate - Metallic Stents
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EC CERTIFICATE Full Quality Assurance System Certificate No.: 10000385425-PA-NA-IND This is to certify that the quality system of: Mitra Industries Private Limited 14/4, Delhi – Mathura Road, Faridabad – 121 003, Haryana, India. For design, production and final product inspection/testing of: Non-Cardiac Stents 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. Place and date: Høvik, 29 April 2021 For the issuing office: Notified Body 2460 DNV Product Assurance AS Alessandra Rinna Assessor Notice: The Certificate is subject to terms and conditions as set out in the Certification Agreement. Failure to comply may render this Certificate invalid. NOTIFIED BODY 2460: DNV Product Assurance AS, Veritasveien 3, 1363 Høvik, Norway, Tel +47 67 57 88 00, www.dnv.com

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Certificate No.: 10000385425-PA-NA-IND Place and date: Hovik, 29 April 2021 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 Issue Date Original Certificate Products covered by this Certificate: Product Description Product Name Esophageal Stent Diameter 12 mm – 35 mm, Length: 60 mm – 170 mm Biliary Stent Diameter 08 mm – 12 mm, Length: 30 mm – 120 mm Colorectal Stent Diameter 22 mm – 35 mm, Length: 60 mm – 170 mm STERILE NON-CARDIAC STENTS...

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Certificate No.: 10000385425-PA-NA-IND Place and date: Hovik, 29 April 2021 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...

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