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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 101-150 of 246

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  • Rightsign Ref WHCG-S11H

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

  • Toto Pharma Ref WHCG-ES11H

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

  • Rightsign Ref MCMIC-LC43

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

  • Rightsign Ref WHCG-ES11

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

  • Rightsign Ref OFTC-C62

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

  • Rightsign Ref MWE2-LC41

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

  • Rightsign Ref WLH-EC11

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

  • Rightsign Ref IFLU-S82

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

  • Rightsign Ref MPIL6-LC41

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

  • Rightsign Ref WAMH-C32

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

  • Rightsign Ref CTNI-C41

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

  • Rightsign Ref MSTC-LC44

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

  • RightSign Ref WCHL-C71P001

    Active Regimes: CE IVDR Registry: EUDAMED Class:C

  • Rightsign Ref IHPC-MC32

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

  • Rightsign Ref MSPTH-LC41

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

  • Rightsign Ref IMON-C41

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

  • Rightsign Ref WLH-C11

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

  • RightSign Ref IFRAD-MC84

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

  • RightSign Ref DETG-C11

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

  • Rightsign Ref MSFEN-LC41

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

  • Rightsign Ref ITYP-C42

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

  • Rightsign Ref INRV-C61

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

  • slovakiapharm Ref WHCG-EM11

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

  • Rightsign Ref INCP-C81

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

  • Rightsign Ref ITB-C31

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

  • Rightsign Ref NMIA-T11

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

  • Rightsign Ref IMPN-C52

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

  • Rightsign Ref MPPCT-LC41

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

  • Rightsign Ref MSTPO-LC41

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

  • Rightsign Ref ICAG-C71

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

  • Rightsign Ref WHCG-EC11H

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

  • Rightsign Ref PCAP-MC62

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

  • Rightsign Ref WLH-EC11H

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

  • RightSign Ref ISTA-S81P001

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Rightsign Ref ISP-C11

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

  • Rightsign Ref IRCF-MC84

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

  • Rightsign Ref IMBD-C47

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

  • Rightsign Ref MWLH-LC41

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

  • Rightsign Ref IHPIV-C81

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

  • RightSign Ref ISTA-C81N001

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Rightsign Ref IMAL-C53

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

  • Rightsign Ref MSFT4-LC41

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

  • RightSign Ref DETG-C11

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • RightSign Ref ISTA-S81N002

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Rightsign Ref ARF-C31

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

  • RightSign Ref WHCG-C21

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • RightSign Ref DETG-DP11

    Active Regimes: CE IVDR Registry: EUDAMED Class:B

  • Rightsign Ref ITB-C41

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

  • Rightsign Ref MIDEN-LC42

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

  • Rightsign Ref MSHAC-LC51

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

Rows 101-150 of 246

Showing 101-150 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