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EC Certificate - Blood Bags

EC Certificate - Blood Bags

Product catalog summary

Certificate Overview:
This document is an EC Certificate for a Full Quality Assurance System issued to Mitra Industries Private Limited for the design, production, and final product inspection/testing of blood bags. The certificate is valid until 26 May 2024 and is issued by DNV Product Assurance AS, a notified body in Norway.

Scope of Certification:
The certification covers blood bags with or without anticoagulant and/or red blood cell preservative solution (SAGM). The blood bags come in various configurations such as single, double, triple, quadruple, and penta, with features like needle safety shields and leukocyte depletion filters. Sizes range from 100ml to 500ml. Transfer bags are also included, with sizes ranging from 100ml to 2000ml.

Compliance and Standards:
The quality system has been assessed according to the conformity assessment procedure described in Annex II, excluding section 4 of Council Directive 93/42/EEC on Medical Devices. The certificate is subject to terms and conditions outlined in the Certification Agreement.

Certificate History:
- Initial issuance on 03 October 2017.
- EC Representative change on 08 July 2020.
- Recertification on 19 March 2021.

Terms and Conditions:
- The manufacturer is liable for any damage caused by defects in the products as per directive 85/374/EEC.
- The certificate is valid only for the listed products and manufacturing premises.
- The manufacturer must maintain the approved quality system and inform the notified body of any updates.
- Periodical audits will be conducted to ensure compliance.

Conformity Declaration:
Upon meeting the terms and conditions, the producer may issue an EC declaration of conformity and affix the CE mark with the notified body identification number.

EU Representative:
Advena Ltd., Tower Business Centre, Malta.

Catalog excerpts

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 covered...

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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 quality...

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