EU Quality Management System Certificate (MDR) Pursuant to Regulation (EU) 2017/745 on Medical Devices, Annex IX Chapters I and III (Class IIa and Class IIb Devices) Authorized Representative: ResMed SAS Parc Technologique de Lyon, 292 Allée Jacques Monod, 69791 Saint Priest Cedex, FRANCE 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 AUSTRALIA The Certification Body of TÜV SÜD Product Service GmbH certifies that the manufacturer has established, documented and implemented a quality management system as described in Article 10 (9) of the Regulation (EU) 2017/745 on medical devices. Details on device categories covered by the quality management system are described on the following page(s). The Report referenced below summarises the result of the assessment and includes reference to relevant CS, harmonized standards and test reports. The conformity assessment has been carried out according to Annex IX Chapter I and III of this regulation with a positive result. The quality management system assessment was accompanied by the assessment of technical documentation for devices selected on a representative basis. The certified quality management system is subject to periodical surveillance by TÜV SÜD Product Service GmbH. The surveillance assessment shall also include an assessment of the technical documentation for the device or devices concerned on the basis of further representative samples. All applicable requirements of the testing and certification regulation of TÜV SÜD Group have to be complied with. For details and certificate validity see: www.tuvsud.com/ps-cert?q=cert:G10 049861 0162 Rev. 02 Report No.: Valid from: Valid until: Date of Initial Issuance: Issue date: Christoph Dicks Head of Certification/Notified Body TÜV SÜD Product Service GmbH is Notified Body with identification no. 0123 TÜV SÜD Product Service GmbH • Certification Body • Ridlerstraße 65 • 80339 M
Open the catalog to page 1Zentralstelle der Lander ^ a. fur Gesundheitsschutz — ^ bei Axzneimitteln und EU Quality Management System Certificate (MDR) Pursuant to Regulation (EU) 2017/745 on Medical Devices, Annex IX Chapters I and III (Class IIa and Class IIb Devices) Classification: Device Group: Intended Purpose: Classification: Device Group: Intended Purpose: Classification: Device Group:Intended Purpose: Classification: Device Group: Intended Purpose: Classification: Device Group: Intended Purpose: Classification: Device Group:Intended Purpose: Classification: Device Group: IIa R020107 - THERMOREGULATED BREATHING...
Open the catalog to page 2Zentralstelle der Lander ^ fur Gesundheitsschutz bei Arzneimitteln und js Medizinprodukten % EU Quality Management System Certificate (MDR) Pursuant to Regulation (EU) 2017/745 on Medical Devices, Annex IX Chapters I and III (Class IIa and Class IIb Devices) Intended Purpose: Classification: Device Group: Intended Purpose: R040199 - VENTILATION FILTERS - OTHER The validity of this certificate -/depends on conditions and/or is limited to the following: Revision History: TUV SUD Product Service GmbH is Notified Body with identification no. 0123 TUV SUD Product Service GmbH • Certification Body...
Open the catalog to page 31 Page
2 Pages
6 Pages
1 Page
2 Pages
2 Pages
2 Pages