BEUDAMED
    Eu Ivdd Eu Ivd Self Testing On The Market 🇹🇼 Taiwan

    THE EDGE

    Apex Biotechnology Corp. · 🇹🇼 Taiwan
    View on EUDAMED
    Devices (same UDI-DI)
    1
    Certificates
    1
    Countries
    6
    Notified Bodies
    1

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    Basic Information

    Primary DI
    D-47136487610ALTZR
    Basic UDI-DI Code
    B-47136487610ALTZR
    Reference
    S5638025
    Device Types
    Single use
    Regulation
    Eu Ivdd
    Classification
    Eu Ivd Self Testing
    Status
    On The Market
    Manufacturer
    Apex Biotechnology Corp.

    Additional Description

    THE EDGE Blood Lactate Test Strips are to be used with THE EDGE Blood Lactate Analyzer to quantitatively measure lactate in capillary whole blood. THE EDGETM Blood Lactate Monitoring System is plasmacalibrated for easy comparison to lab result. THE EDGE Blood Lactate Monitoring System is intended for selftesting by persons with chronic diseases (diabetes ,cardiovascular disease, liver diease, muscular dystrophy) and by health care professionals.

    CND Nomenclature Codes

    Code Description
    W0101060104 LACTATE TEST STRIPS

    Certificates

    Type Number
    IVDD Annex IV (excluding sections 4, 6) HL2100077-1

    Available In Countries

    🇧🇪 Belgium 🇫🇮 Finland 🇵🇱 Poland 🇵🇹 Portugal 🇸🇪 Sweden 🇸🇮 Slovenia

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