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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 151-200 of 246

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  • Rightsign Ref OFOB-S61H

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

  • Rightsign Ref MARF-LC41

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

  • Rightsign Ref IPTG-C41

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

  • RightSign Ref DETG-S11

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Plus Lekaren Ref WHCG-ES11H

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

  • Rightsign Ref MSADA-LC42

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

  • Rightsign Ref PMCP-MC42

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

  • Rightsign Ref MSTG-LC41

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

  • Rightsign Ref MWFSH-LC41

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

  • Rightsign Ref WHCG-EM11

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

  • Rightsign

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

  • Rightsign Ref MCMIC-LC45

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

  • Rightsign Ref IFRA-MC84

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

  • Rightsign Ref WLH-S11H

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

  • Rightsign Ref MSCTX-LC41

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

  • Rightsign Ref IMPF-C51

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

  • Rightsign Ref OCEA-C41

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

  • Rightsign Ref WSTB-C71

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

  • Rightsign Ref MOCA153-LC41

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

  • Rightsign Ref MSTRAB-LC41

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

  • Rightsign Ref MOPGG-LC43

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

  • Rightsign Ref MAANA-LC41

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

  • Rightsign Ref IRAC-C62

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

  • Rightsign Ref IMPF-C51S

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

  • Rightsign Ref MSTST-LC41

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

  • Rightsign Ref WHPV-C72

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

  • Rightsign Ref ILP-C11

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

  • Rightsign Ref IHMV-C81

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

  • Rightsign Ref MSTAU-LC42

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

  • Rightsign Ref ICFRAN-MC85

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

  • Rightsign Ref MWPRL-LC41

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

  • Rightsign Ref ICFR-MC84

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

  • Rightsign Ref MSTT3-LC41

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

  • Rightsign Ref WRUG-C31

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

  • Rightsign Ref IRCFN-MC84

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

  • Rightsign Ref IAST-C61

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

  • Rightsign Ref CDIM-C41

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

  • Rightsign Ref MCHSTN-LC41

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

  • Rightsign Ref OFE-C42

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

  • Rightsign Ref WHCG-C11

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

  • Rightsign Ref MSTT4-LC41

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

  • Rightsign Ref ICFRA-MC85

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

  • Rightsign Ref WFSH-M11

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

  • Rightsign Ref WRUM-C31

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

  • Rightsign Ref MSFA-LC41

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

  • Rightsign Ref SHAC-C51

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

  • Rightsign Ref WHCG-ES11H

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

  • Rightsign Ref MSP1NP-LC41

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

  • Rightsign Ref WHSM-C31

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

  • Rightsign Ref ITET-C41

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

Rows 151-200 of 246

Showing 151-200 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