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

    KET-1 Blood Ketone Monitoring System

    Code: B-47136487609A06R
    View on EUDAMED
    Devices
    1
    Certificates
    1
    Notified Bodies
    1
    Auth. Representatives
    1

    Basic Information

    UDI-DI Code
    B-47136487609A06R
    Issuing Agency
    EUDAMED
    Types
    Kit Instrument Microbial substances Professional testing Self testing Reagent
    Regulation
    Eu Ivdd Legacy
    Classification
    Eu Ivd Self Testing
    Manufacturer
    Apex Biotechnology Corp.
    Last Updated
    August 23, 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    Expired / Withdrawn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 2100077-1 May 26, 2025

    Associated Devices

    This Basic UDI-DI is associated with 1 device.

    Name Status
    KET-1 No longer on the market