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EC Certificate - Blood Bags

EC Certificate - Blood Bags
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EC CERTIFICATE Full Quality Assurance System Certificate No.: 11172-2017-CE-IND-NA-PS Rev.2.0 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: BLOOD BAGS 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, 19 March 2021 For the issuing office: Notified Body 2460 DNV Product Assurance AS Check Validity 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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Place and date: Høvik, 19 March 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 Supersedes DNVGL (NB 0434) Certificate no: 846412010-CE-IND-NA 1.0 following transfer to notified body functions to DNV GL Nemko Presafe AS (NB 2460) 03 October 2017 Certificate No: 11172-2017-CE-IND-NA-PS expiry date 19 September 2020 EC Rep Change 08 July 2020 Certificate No: 11172-2017-CE-IND-NA-PS expiry date 19 September 2020 Products...

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Place and date: Høvik, 19 March 2021 EU Representative Advena Ltd. Tower Business Centre, 2nd Flr., Tower Street Swatar, BKR 4013, Malta 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...

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