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

    HIV Rapid Test Device (Whole blood/Serum/Plasma)

    Code: B-06952804810726
    View on EUDAMED
    Devices
    1
    Certificates
    1
    Notified Bodies
    1
    Auth. Representatives
    3

    Basic Information

    UDI-DI Code
    B-06952804810726
    Issuing Agency
    EUDAMED
    Device Model
    Device
    Types
    Kit Professional testing Reagent
    Regulation
    Eu Ivdd Legacy
    Classification
    Eu Ivd Annex 2 List A
    Manufacturer
    Assure Tech. (Hangzhou) Co., Ltd.
    Last Updated
    December 19, 2022

    Certificate Health

    Total
    1
    Valid
    0
    Expiring < 6mo
    0
    Expired / Withdrawn
    1
    Type Number Expiry Date Status
    IVDD Annex IV Section 4 CeCert/077/W/E.1 May 26, 2025

    Associated Devices

    This Basic UDI-DI is associated with 1 device.

    Name Status
    HIV1/2 Human Immunodeficiency Virus Rapid Test Device (Whole Blood/Serum/Plasma) On the market