Certificate

No. Q6 103129 0001 Rev. 01

Holder of Certificate: Shandong Chengwu Medical

Products Factory
Southern end of Quancheng Road
Chengwu County
274200 Heze City, Shandong Province
PEOPLE'S REPUBLIC OF CHINA

Facility(ies): Shandong Chengwu Medical Products Factory

Southern end of Quancheng Road, Chengwu County, 274200
Heze City, Shandong Province, PEOPLE'S REPUBLIC OF CHINA

Production, Sales and Distribution of Disposable vacuum blood

collection container, Disposable micro blood collection tube,
Disposable sterile venous blood specimen collection needle,
Disposable infusion set.

Certification Mark:

Scope of Certificate: Production, Sales and Distribution of Disposable

Applied Standard(s):
vacuum blood collection container, Disposable
micro blood collection tube, Disposable sterile
venous blood specimen collection needle,
Disposable infusion set.
EN ISO 13485:2016
Medical devices - Quality management systems -
Requirements for regulatory purposes
(ISO 13485:2016)
DIN EN ISO 13485:2016

The Certification Body of TÜV SÜD Product Service GmbH certifies that the company mentioned
above has established and is maintaining a quality management system (excluding subclause 7.3),
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:Q6 103129 0001 Rev. 01
Report No.: BJ22076601
Valid from: 2022-08-02
Valid until: 2025-02-22

Date, 2022-08-02
Christoph Dicks
Head of Certification/Notified Body

Page 1 of 1
TÜV SÜD Product Service GmbH • Certification Body • Ridlerstraße 65 • 80339 Munich • Germany