BEUDAMED
    Basic UDI-DI Eu Ivdd Eu Ivd Annex 2 List B 🇺🇸 United States

    Access Toxo IgM II QC

    Code: B-34479H6
    View on EUDAMED
    Devices
    1
    Certificates
    2
    Notified Bodies
    2
    Auth. Representatives
    1

    Basic Information

    UDI-DI Code
    B-34479H6
    Issuing Agency
    EUDAMED
    Types
    Human tissues Professional testing Reagent
    Regulation
    Eu Ivdd Legacy
    Classification
    Eu Ivd Annex 2 List B
    Manufacturer
    Beckman Coulter Inc.
    Last Updated
    June 10, 2022

    Certificate Health

    Total
    2
    Valid
    0
    Expiring < 6mo
    0
    Expired / Withdrawn
    2
    Type Number Expiry Date Status
    IVDD Annex VII (excluding section 5) 10997 May 26, 2025
    IVDD Annex V 8309 May 26, 2025

    Associated Devices

    This Basic UDI-DI is associated with 1 device.

    Name Status
    Access Toxo IgM II QC On the market