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Iso13485 202311

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0% found this document useful (0 votes)
113 views2 pages

Iso13485 202311

Uploaded by

dashka101316
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
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Certificate

No. Q5 067514 0017 Rev. 03

Holder of Certificate: Beijing M&B Electronic


Instruments Co., Ltd.
Room 6319, Building 1, No.27
Yongwang Road
Daxing Bioengineering and Medicine Industry Base
Zhongguancun Science Park
Daxing District
102629 Beijing
PEOPLE'S REPUBLIC OF CHINA

Certification Mark:

Scope of Certificate: Design and Development, Production, Servicing


and Distribution of Multi-parameter Monitor,
Electrocardiograph, Transcutaneous Jaundice
Detector, Defibrillator, Maternal/ Fetal Portable
Multi-parameter Monitor, Spirometer, AED Pad,
Defibrillator Monitor.

The Certification Body of TÜV SÜD Product Service GmbH certifies that the company mentioned
above has established and is maintaining a quality management system, which meets the
requirements of the listed standard(s). 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:Q5 067514 0017 Rev. 03

Report No.: BJ23096501

Valid from: 2023-11-24


Valid until: 2026-11-23

Date, 2023-11-14 Christoph Dicks


Head of Certification/Notified Body

Page 1 of 2
TÜV SÜD Product Service GmbH • Certification Body • Ridlerstraße 65 • 80339 Munich • Germany
Certificate
No. Q5 067514 0017 Rev. 03

Applied Standard(s): ISO 13485:2016


(EN ISO 13485:2016/AC:2018, EN ISO 13485:2016/A11:2021)
Medical devices - Quality management systems -
Requirements for regulatory purposes

Facility(ies): Beijing M&B Electronic Instruments Co., Ltd.


Room 6319, Building 1, No.27, Yongwang Road, Daxing
Bioengineering and Medicine Industry Base, Zhongguancun
Science Park, Daxing District, 102629 Beijing, PEOPLE'S
REPUBLIC OF CHINA

Management.

Beijing M&B Electronic Instruments Co., Ltd.


4th storey, Building 1, No.27, Yongwang Road, Daxing
Bioengineering and Medicine Industry Base, Zhongguancun
Science Park, Daxing District, 102629 Beijing, PEOPLE'S
REPUBLIC OF CHINA

Design and Development, Production, Servicing and Distribution of


Multi-parameter Monitor, Electrocardiograph, Transcutaneous
Jaundice Detector, Defibrillator, Maternal/ Fetal Portable Multi-
parameter Monitor, Spirometer, AED Pad, Defibrillator Monitor.

Page 2 of 2
TÜV SÜD Product Service GmbH • Certification Body • Ridlerstraße 65 • 80339 Munich • Germany

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