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EC Certificate: No. G1 065725 0019 Rev. 04 Manufacturer: Beijing Aeonmed Co., LTD

The document is an EC Certificate for Beijing Aeonmed Co., Ltd., confirming their Full Quality Assurance System for various medical devices under Directive 93/42/EEC. The certification, issued by TÜV SÜD Product Service GmbH, is valid from May 21, 2021, to May 26, 2024, and requires compliance with periodic surveillance and additional certification for Class III devices. The certificate covers a range of products including anaesthetic workstations, ventilators, and patient monitors.

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Zenebe Abebe
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225 views1 page

EC Certificate: No. G1 065725 0019 Rev. 04 Manufacturer: Beijing Aeonmed Co., LTD

The document is an EC Certificate for Beijing Aeonmed Co., Ltd., confirming their Full Quality Assurance System for various medical devices under Directive 93/42/EEC. The certification, issued by TÜV SÜD Product Service GmbH, is valid from May 21, 2021, to May 26, 2024, and requires compliance with periodic surveillance and additional certification for Class III devices. The certificate covers a range of products including anaesthetic workstations, ventilators, and patient monitors.

Uploaded by

Zenebe Abebe
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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EC Certificate

Full Quality Assurance System


Directive 93/42/EEC on Medical Devices (MDD), Annex II excluding (4)
(Devices in Class IIa, IIb or III)
No. G1 065725 0019 Rev. 04

Manufacturer: Beijing Aeonmed Co., Ltd.


Room 405
Basement 1 to 4th Floor of 901 Unit
Building 9, No.26 Outer Ring West Road
Fengtai District
100070 Beijing
PEOPLE'S REPUBLIC OF CHINA

Product Category(ies): Anaesthetic Workstation, Vaporizer,


Ventilator, Medical Air Compressor,
Infusion Pump, Ceiling Pendant,
Multi-Parameter Patient Monitor,
Videoscope System, Patient Warming System.
The Certification Body of TÜV SÜD 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. 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:G1
065725 0019 Rev. 04

Report No.: BJ19859071

Valid from: 2021-05-21


Valid until: 2024-05-26

Date, 2021-05-21

Christoph Dicks
Head of Certification/Notified Body

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TÜV SÜD Product Service GmbH is Notified Body with identification no. 0123

TÜV SÜD Product Service GmbH • Certification Body • Ridlerstraße 65 • 80339 Munich • Germany

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