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Certificate ES19/86346

Certificate ES19/86346

Product catalog summary
Certificate Overview:
The document certifies that Medical Respiratory Devices, S.L., located at Parque Científico, Avda. de las Américas 4, Nave A7, 28823 Coslada, Madrid, Spain, has a quality management system that meets the requirements of MDSAP (ISO 13485:2016) and Canada's Medical Device Regulations SOR/98-282, Part 1.
Certified Activities:
The certification covers the design, manufacture, and distribution of bacterial and viral filters, nose clips, and disposable mouthpieces for pulmonary function testing equipment.
Certificate Validity:
This certificate is valid from December 3, 2024, to December 3, 2027, subject to satisfactory surveillance audits. The certificate was first issued on August 2, 2019, and this is its third issue.
Certification Authority:
The certificate is authorized by Lynn Henderson of SGS United Kingdom Ltd, located at Rossmore Business Park, Ellesmere Port, Cheshire, UK. SGS UK LTD is recognized under the Medical Devices Single Audit Program.
Additional Information:
The document is an authentic electronic certificate intended for the client's business purposes. Printed versions are considered copies. The certificate is subject to SGS General Conditions of certification services, which include limitations of liability and jurisdictional clauses.
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Catalog excerpts

Certificate ES19/86346-1

Certificate ES19/86346 The quality management system of Medical Respiratory Devices, S.L. Parque Científico, Avda. de las Américas 4, Nave A7, 28823 Coslada, Madrid, Spain Facility number: F002979 has been assessed and certified as meeting the requirements of MDSAP (ISO 13485:2016) Canada: Medical Device Regulations SOR/98-282, Part 1 For the following activities Design, manufacture and distribution of bacterial and viral filters, nose clips and disposable mouthpieces for pulmonary function testing equipment. This certificate is valid from Effective date 2024-12-03 until Expiry date 2027-12-03 and remains valid subject to satisfactory surveillance audits. Issue 3. Certified since 2019-08-02 Authorised by Lynn Henderson SGS United Kingdom Ltd Rossmore Business Park, Ellesmere Port, Cheshire, CH65 3EN, UK t +44 (0)151 350-6666 - www.sgs.com SGS UK LTD is recognised under the Medical Devices Single Audit Program. The validity of this certificate can be verified at www.SGS.com. This document is an authentic electronic certificate for Client’ business purposes use only. Printed version of the electronic certificate are permitted and will be considered as a copy. This document is issued by the Company subject to SGS General Conditions of certification services available on Terms and Conditions | SGS. Attention is drawn to the limitation of liability, indemnification and jurisdictional clauses contained therein. This document is copyright protected and any unauthorized alteration, forgery or falsification of the content or appearance of this document is unlawful.

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