Skip to content

HangZhou Biotest Biotech Co., Ltd.

Active in EUDAMED

Chinafrom SRN EUDAMED FDA SRN CN-MF-000008191 FEI 3011522054

Devices
246
Registrations
EUDAMEDFDA
FDA recalls
0

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.

AI-generated from registry data, 20 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue246

Newest first, rows 201-246 of 246

Search and filter all 246 devices
Skip device list

  • Rightsign Ref WLH-ES11

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Rightsign Ref PCPC-MC46

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Rightsign Ref ICFGN-MC83

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • RightSign Ref ISTA-C81P001

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Rightsign Ref MAIGE-LC41

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Rightsign Ref MSBGP-LC41

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Rightsign Ref WPAMG-C71

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Rightsign Ref CKMB-C41

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Rightsign Ref MSVB-LC41

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Rightsign Ref MIDEG-LC41

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Rightsign Ref OAFP-C41

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Rightsign Ref WLH-S11

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Diagpal Ref RDP-700

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Rightsign Ref IYFC-MC43

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Rightsign Ref IHPB-S41

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Rightsign Ref MWSH6-LC46

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Rightsign Ref IYFB-MC42

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Rightsign Ref WTXM-C31

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD Annex II List B

  • Rightsign Ref ONMP-C11

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Rightsign Ref MSTAB-LC41

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Rightsign Ref WCMG-C31

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD Annex II List B

  • Rightsign Ref PSAA-MC42

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Rightsign Ref WTGM-MC42

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD Annex II List B

  • Rightsign Ref ICBAD-MC83

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Rightsign Ref WHCG-C11H

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD for self-testing

  • RightSign Ref WCHL-C71P002

    Active Regimes: CE IVDR Registry: EUDAMED Class:C

  • Rightsign Ref WLH-M11

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD for self-testing

  • Plus Lekaren Ref WHCG-EM11

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Rightsign Ref IJEV-MC42

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Rightsign Ref IRSVA-C81

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Rightsign Ref ITYP-C32

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Rightsign Ref MOAFP-LC41

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Rightsign Ref PPCT-C43

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Rightsign Ref MWHCG-LC41

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Rightsign Ref STSH-C41

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Rightsign Ref PMXA-C41

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Rightsign Ref OPSA-C42

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD Annex II List B

  • Rightsign Ref IEBA-C61

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Rightsign Ref PCAP-MC63

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Rightsign Ref IROT-C61

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Rightsign Ref AMCD-C43

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Trignostics Ref WLH-ES11H

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD for self-testing

  • RightSign Ref IHCV-C31

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD Annex II List A

  • Trignostics Ref WHCG-EM11

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD for self-testing

  • RightSign Ref IHIV-C42

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD Annex II List A

  • Ferrarihub Ref ISTA-RC81

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

Rows 201-246 of 246

Showing 201-246 of 246

Company details

EUDAMED SRN
CN-MF-000008191
FDA FEI number
3011522054
EU VAT number
9133010079969193XF
EUDAMED status
Active since 2023
EUDAMED registered name
HangZhou Biotest Biotech Co.,Ltd.
Registered address
17 Futai Road, Zhongtai Street, Yuhang District, 311121, Hangzhou, China
PRRC contact
Chao Liu(public in EUDAMED)

EUDAMED certificates2

2 certificates2 valid, 0 expiredIVDR 2next expiry 3 Feb 2031

EUDAMED certificates (2)

Kiwa Sertio Oy 3018 1 certificate

  • EU-QMS-FI-72717-800073-2026 Active

    Quality management system EU IVDR

    Issued
    3 Feb 2026
    Expires
    3 Feb 2031

TÜV SÜD Product Service GmbH 0123 1 certificate

  • V76 077434 0028 Active

    Technical documentation EU IVDR

    Issued
    24 Aug 2026
    Expires
    23 Aug 2031