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EC certificate (MDR)

 EC certificate (MDR)

EC certificate (MDR)

Product catalog summary
Certification Overview: TÜV SÜD Product Service GmbH, a Notified Body with identification no. 0123, has certified that ResMed Pty Ltd has established a quality management system in compliance with Regulation (EU) 2017/745 on medical devices. This certification pertains to Class IIa and Class IIb devices and is valid from August 4, 2022, until October 6, 2025.
Manufacturer and Representative: The manufacturer is ResMed Pty Ltd, located in Bella Vista, Australia, with the authorized representative being ResMed SAS in Saint Priest Cedex, France.
Device Classifications and Groups: The certificate covers several device groups, all classified as IIa, including thermoregulated breathing circuits, CPAP and NIV breathing circuits, anesthesia and pulmonary ventilation support instruments, ventilation masks, anesthesia and resuscitation connectors, breathing circuits and catheter mounts accessories, air/oxygen masks and nasal cannulas, and ventilation filters.
Assessment and Surveillance: The quality management system assessment included a review of technical documentation for selected devices. The system is subject to periodic surveillance by TÜV SÜD Product Service GmbH, which will include further assessments of technical documentation based on representative samples.
Certificate Validity and Conditions: The certificate's validity is contingent upon compliance with TÜV SÜD Group's testing and certification regulations. Details and certificate validity can be verified at www.tuvsud.com/ps-cert?q=cert:G10 049861 0162 Rev. 02.
Revision History: The certificate has undergone revisions, with the initial issuance on October 7, 2020, and subsequent revisions on February 10, 2022, and August 4, 2022.
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Catalog excerpts

 EC certificate (MDR)-1

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

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 EC certificate (MDR)-2

Zentralstelle 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...

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 EC certificate (MDR)-3

Zentralstelle 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...

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