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

    Diagnostic Kit for Quantification of Hepatitis B Virus DNA (PCR-Fluorescence Probing)

    Code: B-06928103000410
    View on EUDAMED
    Devices
    1
    Certificates
    2
    Notified Bodies
    2
    Auth. Representatives
    2

    Basic Information

    UDI-DI Code
    B-06928103000410
    Issuing Agency
    EUDAMED
    Device Model
    Large package, 48 tests/kit
    Types
    Kit Human tissues Microbial substances Professional testing Reagent
    Regulation
    Eu Ivdd Legacy
    Classification
    Eu Ivd Annex 2 List A
    Manufacturer
    Daan Gene Co., Ltd.
    Last Updated
    January 03, 2023

    Certificate Health

    Total
    2
    Valid
    0
    Expiring < 6mo
    0
    Expired / Withdrawn
    2
    Type Number Expiry Date Status
    IVDD Annex IV (excluding sections 4, 6) CeCert/045/W/E.1 May 27, 2025
    IVDD Annex IV Section 4 CeCert/044/W/E.1 May 27, 2025

    Associated Devices

    This Basic UDI-DI is associated with 1 device.

    Name Status
    HEPATITIS B VIRUS - NA REAGENTS On the market