BEUDAMED
    Basic UDI-DI Eu Ivdd Eu Ivd Self Testing 🇹🇼 Taiwan

    β-ketone monitoring system

    Code: B-BC011DZ8
    View on EUDAMED
    Devices
    1
    Certificates
    1
    Notified Bodies
    1
    Auth. Representatives
    1

    Basic Information

    UDI-DI Code
    B-BC011DZ8
    Issuing Agency
    EUDAMED
    Device Model
    BC011D
    Types
    Kit Instrument Professional testing Near patient testing Self testing
    Regulation
    Eu Ivdd Legacy
    Classification
    Eu Ivd Self Testing
    Manufacturer
    General Life Biotechnology Co., Ltd.
    Last Updated
    February 02, 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    Expired / Withdrawn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) HL 2029595-1 May 26, 2025

    Associated Devices

    This Basic UDI-DI is associated with 1 device.

    Name Status
    BeneCheck Knight Blood β-Ketone Monitoring System On the market