BEUDAMED
    Basic UDI-DI Eu Ivdd Eu Ivd Annex 2 List A πŸ‡¦πŸ‡Ί Australia

    HIV Self Test

    Code: B-09349609000204
    View on EUDAMED
    Devices
    1
    Certificates
    2
    Notified Bodies
    2
    Auth. Representatives
    1

    Basic Information

    UDI-DI Code
    B-09349609000204
    Issuing Agency
    EUDAMED
    Device Model
    Galileo Platform
    Types
    Animal tissues Kit Microbial substances Near patient testing Self testing Reagent
    Regulation
    Eu Ivdd Legacy
    Classification
    Eu Ivd Annex 2 List A
    Manufacturer
    Atomo Diagnostics Limited
    Last Updated
    June 22, 2022

    Certificate Health

    Total
    2
    Valid
    0
    Expiring < 6mo
    0
    Expired / Withdrawn
    2
    Type Number Expiry Date Status
    IVDD Annex IV Section 4 716015 May 26, 2025
    IVDD Annex IV (excluding sections 4, 6) 637070 May 26, 2025

    Associated Devices

    This Basic UDI-DI is associated with 1 device.

    Name Status
    Simplitude ByMe On the market