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

    PSA Prostate Specific Antigen Semi-Quantitative Ultra Rapid Test Device (Whole Blood/Serum/Plasma)

    Code: B-TPS-U402U6
    View on EUDAMED
    Devices
    1
    Certificates
    1
    Notified Bodies
    1
    Auth. Representatives
    1

    Basic Information

    UDI-DI Code
    B-TPS-U402U6
    Issuing Agency
    EUDAMED
    Device Model
    TPS-U402
    Types
    Animal tissues Kit Professional testing Reagent
    Regulation
    Eu Ivdd Legacy
    Classification
    Eu Ivd Annex 2 List B
    Manufacturer
    Abon Biopharm(Hangzhou) Co., Ltd
    Last Updated
    November 22, 2023

    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    Expired / Withdrawn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 058228 0009 Jan 16, 2025

    Associated Devices

    This Basic UDI-DI is associated with 1 device.

    Name Status
    PSA - RT & POC On the market