BEUDAMED
    Basic UDI-DI Eu Ivdd Eu Ivd Annex 2 List A 🇨🇳 China

    HBsAg Hepatitis B Surface Antigen Rapid Test Device (Whole Blood/Serum/Plasma)

    Code: B-06952999407428
    View on EUDAMED
    Devices
    1
    Certificates
    2
    Notified Bodies
    2
    Auth. Representatives
    1

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    Basic Information

    UDI-DI Code
    B-06952999407428
    Issuing Agency
    EUDAMED
    Device Model
    IHBsg-402
    Types
    Animal tissues Kit Microbial substances Professional testing Reagent
    Regulation
    Eu Ivdd Legacy
    Classification
    Eu Ivd Annex 2 List A
    Manufacturer
    Abon Biopharm(Hangzhou) Co., Ltd
    Last Updated
    November 21, 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    Expired / Withdrawn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) No. 11 0497 QS/NB May 26, 2025
    IVDD Annex IV Section 4 No. 11 0498 CN/NB May 26, 2025

    Associated Devices

    This Basic UDI-DI is associated with 1 device.

    Name Status
    HBSAG - RT & POC On the market