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    Eu Ivdd Eu Ivd Annex 2 List B No Longer On The Market 🇹🇼 Taiwan

    MultiSure GCTU

    Apex Biotechnology Corp. · 🇹🇼 Taiwan
    View on EUDAMED
    Devices (same UDI-DI)
    1
    Certificates
    1
    Countries
    0
    Notified Bodies
    1

    Basic Information

    Primary DI
    D-47136487613A062
    Basic UDI-DI Code
    B-47136487613A062
    Reference
    S81001, S81002
    Device Types
    Single use
    Regulation
    Eu Ivdd
    Classification
    Eu Ivd Annex 2 List B
    Status
    No Longer On The Market
    Manufacturer
    Apex Biotechnology Corp.

    Additional Description

    The MultiSure GCTU Monitoring System is intended for quantitative measurement of glucose, cholesterol, triglyceride and uric acid level in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for self-testing by individuals at home or for clinical settings by healthcare professional, as an aid in monitoring blood glucose, cholesterol, triglyceride and uric acid level. The MultiSure GCTU system is not intended for diagnosis or screening of diabetes, or for neonatal use.

    CND Nomenclature Codes

    Code Description
    W010106010801 BLOOD TEST STRIPS CONTROLS
    W0101060199 BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
    W0101060105 TRIGLYCERIDE TEST STRIPS
    W0101060102 CHOLESTEROL TEST STRIPS
    W0101060101 GLUCOSE TEST STRIPS
    W020106019099 VARIOUS DIABETES MONITORING INSTRUMENTS - OTHER

    Certificates

    Type Number
    IVDD Annex IV (excluding sections 4, 6) HL 2100077-1

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