HangZhou Biotest Biotech Co.,Ltd.
China CN-MF-000008191 Last updated 8 Jun 2026
Is this your brand? Sign in to claim this brand
- Devices
- 122
- Registries
- EUDAMED
- FDA recalls
- 0
Catalogue
Rightsign Ref ITB-C31
Rightsign Ref NMIA-T11
Rightsign Ref IMPN-C52
Rightsign Ref MPPCT-LC41
Rightsign Ref MSTPO-LC41
Rightsign Ref ICAG-C71
Rightsign Ref WHCG-EC11H
Rightsign Ref PCAP-MC62
Rightsign Ref WLH-EC11H
RightSign Ref ISTA-S81P001
Rightsign Ref ISP-C11
Rightsign Ref IRCF-MC84
Rightsign Ref IMBD-C47
Rightsign Ref MWLH-LC41
Rightsign Ref IHPIV-C81
RightSign Ref ISTA-C81N001
Rightsign Ref IMAL-C53
Rightsign Ref MSFT4-LC41
RightSign Ref DETG-C11
RightSign Ref ISTA-S81N002
Rightsign Ref ARF-C31
RightSign Ref WHCG-C21
RightSign Ref DETG-DP11
Rightsign Ref ITB-C41
Rightsign Ref MIDEN-LC42
Rightsign Ref MSHAC-LC51
Rightsign Ref OFOB-S61H
Rightsign Ref MARF-LC41
Rightsign Ref IPTG-C41
RightSign Ref DETG-S11
Plus Lekaren Ref WHCG-ES11H
Rightsign Ref MSADA-LC42
Rightsign Ref PMCP-MC42
Rightsign Ref MSTG-LC41
Rightsign Ref MWFSH-LC41
Rightsign Ref WHCG-EM11
Rightsign Ref WIGF-C71;WIGF-S71
Rightsign Ref MCMIC-LC45
Rightsign Ref IFRA-MC84
Rightsign Ref WLH-S11H
Rightsign Ref MSCTX-LC41
Rightsign Ref IMPF-C51
Rightsign Ref OCEA-C41
Rightsign Ref WSTB-C71
Rightsign Ref MOCA153-LC41
Rightsign Ref MSTRAB-LC41
Rightsign Ref MOPGG-LC43
Rightsign Ref MAANA-LC41
Rightsign Ref IRAC-C62
Rightsign Ref IMPF-C51S
Showing 1-50 of 122
EUDAMED certificates
Notified body 3018 1 certificate
- EU-QMS-FI-72717-800073-2026 Issued
Quality management system EU IVDR
- Issued
- 3 Feb 2026
- Expires
- 3 Feb 2031
TÜV SÜD Product Service GmbH 0123 1 certificate
- V76 077434 0028 Issued
Technical documentation EU IVDR
- Issued
- 24 Aug 2026
- Expires
- 23 Aug 2031
Related companies
Authorised representatives
Notified bodies
- TÜV SÜD Product Service GmbH 0123
- Notified body 3018
What HangZhou Biotest Biotech Co.,Ltd. makes
HangZhou Biotest Biotech Co.,Ltd. makes in vitro diagnostic (IVD) devices, including products such as RightSign and TRIGNOSTICS, which are used for diagnostic testing. These devices are designed for various applications, including self-testing. The company's portfolio includes a range of IVD devices, such as Ferrarihub.
The company's devices are classified as IVD Annex II List A, IVD General, and IVD devices for self-testing, and are listed in the Eudamed registry. The company is based in China.
Frequently asked questions
What type of devices does HangZhou Biotest Biotech Co.,Ltd. manufacture?
The company makes in vitro diagnostic (IVD) devices, including products like RightSign and TRIGNOSTICS, used for diagnostic testing, because these are listed as example devices.
Where is HangZhou Biotest Biotech Co.,Ltd. based?
The company is based in China, as indicated by its country code CN.
Which registry lists HangZhou Biotest Biotech Co.,Ltd.'s devices?
The company's devices are listed in the Eudamed registry, which is a database of medical devices.
How are HangZhou Biotest Biotech Co.,Ltd.'s devices classified?
The devices are classified as IVD Annex II List A, IVD General, and IVD devices for self-testing, because these classifications are specified for the company's devices.
Information
- Country
- China
- Address
- 17 Futai Road, Zhongtai Street, Yuhang District, Hangzhou, China
- Website
- biotests.com.cn
- [email protected]
- PRRC contact
- Chao Liu
- EUDAMED SRN
- CN-MF-000008191