Certificate Number 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 identification number: F002979 has been audited against the criteria stated below and found to conform to those criteria for the scope contained in this certificate MDSAP(ISO 13485:2016) Canada: Medical Devices Regulations – Part 1 SOR 98/282 United States: 21 CFR 820 / 21 CFR 803 / 21 CFR 806 / 21 CFR 807 – Subparts A to D For the following activities and devices 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: 2022-08-01 until Expiry Date: 2024-12-03 and remains valid subject to satisfactory surveillance audits. Re certification audit due before 2024-10-03 Issue 2. Certified since 2019-08-02 Authorised by LHenderson Business Manager SGS United Kingdom Ltd Rossmore Business Park, Ellesmere Port ,Cheshire, CH65 3EN,UK t +44 (0)151 3506666 www.sgs.com SGS United Kingdom Ltd is an MDSAP authorised auditing organization SGS MDSAP 1116 Page 1 of 1 This document is issued by the Company subject to its General Conditions of Certification Services accessible at www.sgs.com/terms_and_conditions.htm. Attention is drawn to the limitations of liability, indemnification and jurisdictional issues established therein. The authenticity of this document may be verified at http://www.sgs.com/en/certified-clients-and-products/certified-client-directory. Any unauthorized alteration, forgery or falsification of the content or appearance of this document is unlawful and offenders may be prosecuted to the fullest extent of the l