BEUDAMED
    Basic UDI-DI Eu Ivdd Eu Ivd Annex 2 List B 🇨🇳 China

    Chemiluminescent Immunoassay Assay Kits for Free Prostate Specific Antigen (t-PSA)

    Code: B-EIM4403106FN
    View on EUDAMED
    Devices
    1
    Certificates
    1
    Notified Bodies
    1
    Auth. Representatives
    3

    Basic Information

    UDI-DI Code
    B-EIM4403106FN
    Issuing Agency
    EUDAMED
    Device Model
    total PSA (CLIA)
    Types
    Animal tissues Kit Human tissues Professional testing Reagent
    Regulation
    Eu Ivdd Legacy
    Classification
    Eu Ivd Annex 2 List B
    Manufacturer
    Maccura Biotechnology Co., Ltd.
    Last Updated
    May 23, 2022

    Certificate Health

    Total
    1
    Valid
    0
    Expiring < 6mo
    0
    Expired / Withdrawn
    1
    Type Number Expiry Date Status
    IVDD Annex IV (excluding sections 4, 6) No. V1 059892 0009 May 26, 2025

    Associated Devices

    This Basic UDI-DI is associated with 1 device.

    Name Status
    TOTAL PROSTATIC SPECIFIC ANTIGEN On the market