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Acon Biotech (Hangzhou) Co., Ltd. — Manufacturer in China

MD Atlas update: Sep 24, 2026

AB

Acon Biotech (Hangzhou) Co., Ltd.

China

All roles followed

Views by role

Sources: EUDAMED

Legal information of Acon Biotech (Hangzhou) Co., Ltd.

Legal name: Acon Biotech (Hangzhou) Co., Ltd.
EU VAT number: 913301006091684447
SRN (displayed role): CN-MF-000006977
EUDAMED status: Active· registered in 2021
Registered office: Zhenzhong Road, No.210 310030 Hangzhou, China

Contact details for Acon Biotech (Hangzhou) Co., Ltd.

Phone: +86 571 87775615
Email: alyssa.lu@aconlab.com.cn
Website: https://www.aconbio.com/index.html
Address: NO.210, ZHENZHONG ROAD WEST LAKE DISTRICT 310030 HANGZHOU CHINA

Data export

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Medical device manufacturers in EUDAMED

Competent authority for Acon Biotech (Hangzhou) Co., Ltd.

DE/CA22 - Bezirksregierung Münster
GermanyContact the authority →

Certificates of Acon Biotech (Hangzhou) Co., Ltd.

Executives & regulatory representatives of Acon Biotech (Hangzhou) Co., Ltd.

4 contacts identified

XU Andy
PRRC
View profile →
YOU Junny
PRRC
View profile →
XU Andy
Ensure the conformity of the device before released; ensure the post-market surveillance system is implemented and keep up to date; fulfill the reporting obligations referred to the Vigilance system.
Hidden
YOU Junny
Ensure the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date.
Hidden

695Total Devices

541Basic UDI-DIs

5Certificates5 valid · 0 expiring < 12 months

32CountriesEU/EEA placements

Market presence of Acon Biotech (Hangzhou) Co., Ltd.

Devices placed in 32 countries

Risk categories of Acon Biotech (Hangzhou) Co., Ltd.

Related documents of Acon Biotech (Hangzhou) Co., Ltd.

Technical documentation

Certificate V76 042074 0046Rev. Rev. 00

Issued

Manufacturer

Acon Biotech (Hangzhou) Co., Ltd.

Notified body

TÜV SÜD Product Service GmbH

0123

Version

1

Valid from

7/21/2026

Valid until

7/20/2031

Technical documentation

Certificate V76 042074 0043Rev. Rev. 00

Issued

Manufacturer

Acon Biotech (Hangzhou) Co., Ltd.

Notified body

TÜV SÜD Product Service GmbH

0123

Version

1

Valid from

7/13/2026

Valid until

7/12/2031

Technical documentation

Certificate V76 042074 0045Rev. Rev. 00

Issued

Manufacturer

Acon Biotech (Hangzhou) Co., Ltd.

Notified body

TÜV SÜD Product Service GmbH

0123

Version

1

Valid from

7/13/2026

Valid until

7/12/2031

Technical documentation

Certificate V76 042074 0044Rev. Rev. 00

Issued

Manufacturer

Acon Biotech (Hangzhou) Co., Ltd.

Notified body

TÜV SÜD Product Service GmbH

0123

Version

1

Valid from

7/14/2026

Valid until

7/13/2031

Quality management system

Certificate V13 042074 0039Rev. Rev. 02

Supplemented

Manufacturer

Acon Biotech (Hangzhou) Co., Ltd.

Notified body

TÜV SÜD Product Service GmbH

0123

Version

2

Valid from

7/7/2026

Valid until

4/9/2030

Cartography of Acon Biotech (Hangzhou) Co., Ltd.

Authorised representativeNotified bodiesPeople

TÜV SÜD Product Service GmbH — 5 certificates — Acon Biotech (Hangzhou) Co., Ltd.
MedNet EC-REP GmbH — represents — Acon Biotech (Hangzhou) Co., Ltd.
XU Andy — Acon Biotech (Hangzhou) Co., Ltd.
YOU Junny — Acon Biotech (Hangzhou) Co., Ltd.

Catalog of Acon Biotech (Hangzhou) Co., Ltd.

695 devices · 620 families

Filter

SARS-CoV-2 Antigen Rapid Test Lollipop (Saliva)1 version
Sample Collection Kit1 version
Influenza A/B Rapid Test (Self-Testing)1 version
U120 Smart Urine Analyzer2 versions
MultiPro AnalyzerOGM-2212 versions
U500 Urine Analyzer4 versions
NES-32 Nucleic Acid Extraction System1 version
FIA AnalyzeriFIA-1002 versions
Viral Nucleic Acid Isolation Kit1 version
Viral DNA/RNA Isolation Kit2 versions
Nucleic Acid (RNA) Extraction Kit3 versions
Nucleic Acid (DNA) Extraction Kit3 versions
960 Real-Time PCR SystemRTQ-9601 version
Expert U500 Urine Analyzer 4 versions
Expert U120 Smart Urine Analyzer4 versions
3D Hematology Reagent6 versions
Whole Blood Genomic DNA Extraction Kit2 versions
Nucleic Acid Extraction Kit1 version
Viral transport media11 versions
On Call Extra Blood Glucose MeterOGM-1911 version
On Call Extra Blood Gucose Test StripsOGS-1911 version
On Call Extra Blood Gucose Test StripsOGS-1911 version
On Call Extra Glucose Control SolutionOGC-1911 version
On Call Sure Blood Glucose Monitoring SystemOGM-2111 version
On Call Sure Blood Glucose MeterOGM-2111 version

620 families

Page 1 of 25

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