BEUDAMED
    Basic UDI-DI Eu Ivdd Eu Ivd Annex 2 List A πŸ‡¨πŸ‡¦ Canada

    INSTI HIV ANTIBODY SELF-TEST, CE, ETLVLT

    Code: B-00686597200889
    View on EUDAMED
    Devices
    1
    Certificates
    2
    Notified Bodies
    2
    Auth. Representatives
    2

    Basic Information

    UDI-DI Code
    B-00686597200889
    Issuing Agency
    EUDAMED
    Device Model
    90-1123
    Types
    Kit Self testing
    Regulation
    Eu Ivdd Legacy
    Classification
    Eu Ivd Annex 2 List A
    Manufacturer
    bioLytical Laboratories Inc.
    Last Updated
    June 16, 2022

    Certificate Health

    Total
    2
    Valid
    0
    Expiring < 6mo
    0
    Expired / Withdrawn
    2
    Type Number Expiry Date Status
    IVDD Annex IV (excluding sections 4, 6) DGM-549 May 26, 2024
    IVDD Annex IV Section 4 DGM-548 May 26, 2024

    Associated Devices

    This Basic UDI-DI is associated with 1 device.

    Name Status
    INSTI HIV Self Test On the market