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-47136487610ALSZP
    Basic UDI-DI Code
    B-47136487610ALSZP
    Reference
    S5800024
    Device Types
    None provided
    Regulation
    Eu Ivdd
    Classification
    Eu Ivd Self Testing
    Status
    On The Market
    Manufacturer
    Apex Biotechnology Corp.

    Additional Description

    The purpose of the control solution test is to validate the performance of THE EDGE Blood Lactate Monitoring System using a standard solution with a known range of lactate. A control solution test that falls within the acceptable range means the user's technique is an appropriate and both of the meter and test strip are functioning properly.

    CND Nomenclature Codes

    Code Description
    W010106010801 BLOOD TEST STRIPS CONTROLS

    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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