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

    Fortel Prostate (PSA) Screening Test

    Code: B-00083059108118
    View on EUDAMED
    Devices
    1
    Certificates
    1
    Notified Bodies
    1
    Auth. Representatives
    1

    Basic Information

    UDI-DI Code
    B-00083059108118
    Issuing Agency
    EUDAMED
    Device Model
    1081-1
    Types
    Animal tissues Kit Near patient testing Self testing
    Regulation
    Eu Ivdd Legacy
    Classification
    Eu Ivd Annex 2 List B
    Manufacturer
    Biomerica, Inc.
    Last Updated
    September 24, 2024

    Certificate Health

    Total
    1
    Valid
    0
    Expiring < 6mo
    0
    Expired / Withdrawn
    1
    Type Number Expiry Date Status
    IVDD Annex IV (excluding sections 4, 6) 20560 May 26, 2025

    Associated Devices

    This Basic UDI-DI is associated with 1 device.

    Name Status
    Fortel® Prostate (PSA) Screening Test On the market