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ISO 13485 - 2016 Certificate

ISO 13485 - 2016 Certificate

Product catalog summary
Certificate Overview:
This document is a Management System Certificate issued to Mitra Industries Pvt. Ltd., located at 14/4, Delhi-Mathura Road, Faridabad, India. The certificate number is 245953-2017-AQ-IND-NA-PS Rev. 1.0, and it was initially certified on 11 March 2019, valid until 11 March 2022.

Certification Authority:
The certificate is issued by DNV GL PRESAFE AS, based in Høvik, Norway. It has been digitally signed by Eugenie Winger Husebye.

Compliance Standard:
The management system of Mitra Industries complies with ISO 13485:2016/NS-EN ISO 13485:2016 standards.

Scope of Certification:
The certification covers the design, manufacture, sale, and distribution of various medical products, including:
  • Blood Bags
  • Continuous Ambulatory Peritoneal Dialysis (CAPD) Bags
  • CAPD Bag Accessories
  • Non-Cardiac Stents
  • Sterilized Titanium Adapters
  • Non-Sterile Blood Bank & Dialysis Equipment

Additional Information:
The certificate is subject to terms and conditions outlined in the Certification Agreement, and non-compliance may invalidate the certificate. For more information on the digital signature, visit www.presafe.com/digital_signatures.
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Catalog excerpts

ISO 13485 - 2016 Certificate-1

Management System Certificate Initial Certification Date: Valid Until: This is to certify that the management system of: Mitra Industries Pvt. Ltd. 14/4, DELHI-MATHURA ROAD, 121003 Faridabad India Complies with the requirements of: ISO 13485:2016/NS-EN ISO 13485:2016 The Certificate is valid for the following scope: Design, Manufacture, Sale and Distribution of all Types of Blood Bags, Continuous Ambulatory Peritoneal Dialysis Bags, CAPD Bag Accessories, Non-Cardiac Stents, Sterilized Titanium Adapters, Non-Sterile Blood Bank & Dialysis Equipment's Eugenie Winger Husebye MSYS 018 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 Agr eement. Failure to comply may render this Certificate invalid. DNV GL PRESAFE AS - Veritasv eien 3, N-1363 Høv ik, Norway - Registered Enterprise No: NO 997 067 401 MVA

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