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Certificate

No. Q6 065764 0006 Rev. 03

Holder of Certificate: Hebei Xinle Sci&Tech Co.,Ltd


No.2, Xingye Street, Xinle City
050700 Shijiazhuang City, Hebei Province
PEOPLE'S REPUBLIC OF CHINA

Facility(ies): Hebei Xinle Sci&Tech Co.,Ltd


No.2, Xingye Street, Xinle City, 050700 Shijiazhuang City, Hebei
Province, PEOPLE'S REPUBLIC OF CHINA

Production, Sales and Distribution of Single-use Containers for


Human Venous Blood Specimen Collection, Venous Blood
Collection Needles, Lancet, Single-use Containers for Human
Capillary Blood Specimen Collection, Disposable Virus Sampling
Tube.
Certification Mark:

Scope of Certificate: Production, Sales and Distribution of Single-use


Containers for Human Venous Blood Specimen
Collection, Venous Blood Collection Needles,
Lancet, Single-use Containers for Human Capillary
Blood Specimen Collection, Disposable Virus
Sampling Tube.
Applied Standard(s): 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 065764 0006 Rev. 03
Report No.: BJ21096101

Valid from: 2022-07-06


Valid until: 2023-09-11

Date, 2022-07-06
Christoph Dicks
Head of Certification/Notified Body

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

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