Certificate

No. Q5 043324 0034 Rev. 00

Holder of Certificate: Guangzhou Improve

Medical Instruments Co., Ltd.
No.102, Kaiyuan Avenue Science City
Guangzhou Economic &
Technological Development District
510530 Guangzhou
PEOPLE'S REPUBLIC OF CHINA

Certification Mark:

Scope of Certificate: Design, Development Production and Distribution of

Evacuated Blood Collection Tube, Blood Collection
Needle, Blood Lancet, Microbiological Transport Swab,
ESR Fast Detector, Capillary Blood Collection Tube,
Holder, Tourniquet, Automatic Decapper, Urine
Collection Tube, Automated Erythrocyte Sedimentation
Rate (ESR) Analyzer, Scalp Vein Set, Sterile Safety
Auto-disable Syringe with Needle, Intravenous Catheter
for Single Use, Thrombelastograph Analysis System
include Test Kits and Analyzers, Specimen Container,
Specimen Transfer Device，Viral Preservative Medium
(VPM)，NAT Medium, Saliva Collection Kit, Disposable
Swab

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 043324 0034 Rev. 00

Report No.: SH22212A02

Valid from: 2022-07-01

Valid until: 2025-06-30

Date, 2022-07-01 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 043324 0034 Rev. 00

Applied Standard(s): EN ISO 13485:2016

Medical devices - Quality management systems -
Requirements for regulatory purposes
(ISO 13485:2016)
DIN EN ISO 13485:2016

Facility(ies): Guangzhou Improve Medical Instruments Co., Ltd.

No.102, Kaiyuan Avenue Science City, Guangzhou
Economic &, Technological Development District, 510530
Guangzhou, PEOPLE'S REPUBLIC OF CHINA

See Scope of Certificate

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