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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 51-100 of 246

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  • Rightsign Ref MCKMB-LC41

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

  • Rightsign Ref MACCP-LC41

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

  • Rightsign Ref IGL-C61

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

  • Rightsign Ref NURS-T1X

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

  • Rightsign Ref MADNA-LC41

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

  • Rightsign Ref MCMYO-LC41

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

  • Rightsign Ref WHCG-M11

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

  • Rightsign Ref IMPV-C52S

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

  • Rightsign Ref IADE-C81

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

  • Rightsign Ref MSTC-LC45

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

  • Rightsign Ref SCJ-C61

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

  • Rightsign Ref WIGFF-C72

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

  • Rightsign Ref MSFT3-LC41

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

  • Rightsign Ref OFE-C41

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

  • Rightsign Ref OCA15-C42

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

  • Rightsign Ref MOCA125-LC41

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

  • Rightsign Ref WHCG-EC11

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

  • Rightsign Ref OBTA-C11

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

  • Rightsign Ref IZGM-C42

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

  • Rightsign Ref MCCPC-LC42

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

  • Rightsign Ref IHAV-C41

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

  • Rightsign Ref MPSAA-LC31

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

  • Rightsign Ref MPROG-LC41

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

  • Rightsign Ref SCAR-MC95

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

  • Rightsign Ref OLF-C61

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

  • Rightsign Ref IRCF-MC84S

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

  • Rightsign Ref INGM-MC42

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

  • Rightsign Ref MCCRP-LC41

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

  • Rightsign Ref MSTSH-LC41

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

  • Rightsign Ref ICGT-C63

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

  • Rightsign Ref IMPN-C52S

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

  • Rightsign Ref MNMG-LC41

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

  • Rightsign Ref AGLU-C51

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

  • RightSign Ref DETG-P11

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Rightsign Ref MOCA199-LC41

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

  • Rightsign Ref MCTNI-LC41

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

  • Rightsign Ref ICOVN-C81H

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

  • RightSign Ref DETG-C11

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Rightsign Ref MWAMH-LC41

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

  • Rightsign Ref CBNP-C41

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

  • Rightsign Ref IARAN-MC65

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

  • Rightsign Ref IGEC-C63

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

  • Rightsign Ref AG6PD-C51

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

  • Rightsign Ref MIHPG-LC31

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

  • Rightsign Ref IHAGM-C32

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

  • RightSign Ref ISTA-S81N001

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Rightsign Ref MOCEA-LC41

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

  • Rightsign Ref MCDIM-LC41

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

  • Rightsign Ref CCRP-C42

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

  • Rightsign Ref MCBNP-LC41

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

Rows 51-100 of 246

Showing 51-100 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