BEUDAMED
    Basic UDI-DI Eu Ivdd Eu Ivd Self Testing πŸ‡¨πŸ‡³ China

    Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Assay Kit by Colloidal Gold Method

    Code: B-EPLIM410308369
    View on EUDAMED
    Devices
    1
    Certificates
    1
    Notified Bodies
    1
    Auth. Representatives
    3

    Basic Information

    UDI-DI Code
    B-EPLIM410308369
    Issuing Agency
    EUDAMED
    Types
    Animal tissues Kit Self testing Reagent
    Regulation
    Eu Ivdd Legacy
    Classification
    Eu Ivd Self Testing
    Manufacturer
    Maccura Biotechnology Co., Ltd.
    Last Updated
    May 25, 2022

    Certificate Health

    Total
    1
    Valid
    0
    Expiring < 6mo
    0
    Expired / Withdrawn
    1
    Type Number Expiry Date Status
    IVDD Annex III Section 6 1434-IVDD-174/2022 May 27, 2025

    Associated Devices

    This Basic UDI-DI is associated with 1 device.

    Name Status
    CORONAVIRUS [obsolete from 2025-01-01] On the market