BEUDAMED
    Basic UDI-DI Eu Ivdd Eu Ivd Annex 2 List B 🇹🇼 Taiwan

    HLAssure™ SE B Locus SBT Kit, 24 tests/kit

    Code: B-47180503600502106K4R
    View on EUDAMED
    Devices
    1
    Certificates
    1
    Notified Bodies
    1
    Auth. Representatives
    1

    Basic Information

    UDI-DI Code
    B-47180503600502106K4R
    Issuing Agency
    EUDAMED
    Device Model
    50210
    Types
    Companion diagnostics Kit Professional testing Near patient testing Reagent
    Regulation
    Eu Ivdd Legacy
    Classification
    Eu Ivd Annex 2 List B
    Manufacturer
    TBG Biotechnology Corp.
    Last Updated
    November 16, 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    Expired / Withdrawn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) HL 2057895-1 May 26, 2025

    Associated Devices

    This Basic UDI-DI is associated with 1 device.

    Name Status
    HLAssure™ SE B Locus SBT Kit, 24 tests/kit On the market