BEUDAMED
    Basic UDI-DI Eu Ivdd Eu Ivd Annex 2 List A πŸ‡¨πŸ‡³ China

    Nucleic Acid Test Kit for HBV, HCV, HIV (Type1+2) (Real-time PCR)

    Code: B-06974960210004
    View on EUDAMED
    Devices
    1
    Certificates
    2
    Notified Bodies
    2
    Auth. Representatives
    2

    Basic Information

    UDI-DI Code
    B-06974960210004
    Issuing Agency
    EUDAMED
    Types
    Kit Microbial substances Professional testing Reagent
    Regulation
    Eu Ivdd Legacy
    Classification
    Eu Ivd Annex 2 List A
    Manufacturer
    Sanway Gene Tech. Inc.
    Last Updated
    January 20, 2025

    Certificate Health

    Total
    2
    Valid
    0
    Expiring < 6mo
    0
    Expired / Withdrawn
    2
    Type Number Expiry Date Status
    IVDD Annex IV (excluding sections 4, 6) 1434-IVDD-199/2022 May 27, 2025
    IVDD Annex IV Section 4 1434-IVDD-198/2022 May 27, 2025

    Associated Devices

    This Basic UDI-DI is associated with 1 device.

    Name Status
    HBV / HCV / HIV COMBINATION - MULTIPLEX NA REAGENTS On the market