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EC certificate (MDD)
1 /2Pages

EC certificate (MDD)

EC certificate (MDD)
1 /2Pages

Catalog excerpts

EC certificate (MDD)-1

Benannt durch/Designated by Zentralstelle der Lander -S fiir Gesundheitsschutz S' bei Arzneimitteln und i Medizinprodukten £ EC Certificate Full Quality Assurance System Directive 93/42/EEC on Medical Devices (MDD), Annex II excluding (4) (Devices in Class lla, lib or III) Manufacturer: ResMed Pty Ltd1 Elizabeth Macarthur Drive Bella Vista NSW 2153 AUSTRALIA Product Category(ies): Positive Airway Pressure Devices, The Certification Body of TUV SUD Product Service GmbH declares that the aforementioned manufacturer has implemented a quality assurance system for design, manufacture and final inspection of the respective devices / device categories in accordance with MDD Annex II. This quality assurance system conforms to the requirements of this Directive and is subject to periodical surveillance. For marketing of class III devices an additional Annex II (4) certificate is mandatory. See also notes overleaf. Valid from: Valid until: Date, 2019-12-04 JAQ235040503 2019-12-04 2024-05-26 TUV SUD Product Service GmbH is Notified Body with identification no. 0123 TUV SUD Product Service GmbH • Certification Body • Ridlerstralie 65 • 80339 Munich • Germany

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EC certificate (MDD)-2

Benannt durch/Designated by Zentralstelle der Lander S fur Gesundheitsschutz S' bei Arzneimitteln und g Medizinprodukten | EC Certificate Full Quality Assurance System Directive 93/42/EEC on Medical Devices (MDD), Annex II excluding (4) (Devices in Class lla, Mb or III) Facility(ies): ResMed Pty Ltd1 Elizabeth Macarthur Drive, Bella Vista NSW 2153, AUSTRALIA -/- TUV SUD Product Service GmbH is Notified Body with identification no. 0123 TUV SUD Product Service GmbH • Certification Body • RidlerstrafSe 65 • 80339 Munich • Germany

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