BEUDAMED
    Eu Ivdd Eu Ivd Self Testing On The Market 🇨🇳 China

    QUIK-CHECK Ultra Cholesterol Monitoring System

    Acon Biotech (Hangzhou) Co., Ltd. · 🇨🇳 China
    View on EUDAMED
    Devices (same UDI-DI)
    1
    Certificates
    1
    Countries
    0
    Notified Bodies
    1

    Basic Information

    Primary DI
    D-C111-5017RT
    Basic UDI-DI Code
    B-C111-5017RT
    Reference
    C111-5017
    Device Types
    None provided
    Regulation
    Eu Ivdd
    Classification
    Eu Ivd Self Testing
    Status
    On The Market
    Manufacturer
    Acon Biotech (Hangzhou) Co., Ltd.

    Additional Description

    The QUIK-CHECK Ultra Cholesterol Monitoring System is intended for the quantitative determination of Total Cholesterol in fresh fingertip capillary whole blood as an aid in diagnosis of atherosclerotic coronary artery disease and metabolic disorders involving lipids and lipoproteins. The Ultra Cholesterol Monitoring System consists of Ultra Cholesterol Meter, Ultra Total Cholesterol Test Strips and Ultra Cholesterol Control Solution and it is for self-testing and professional use.

    CND Nomenclature Codes

    Code Description
    W010106010801 BLOOD TEST STRIPS CONTROLS
    W0101060102 CHOLESTEROL TEST STRIPS
    W0201069099 VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER

    Certificates

    Type Number
    IVDD Annex IV (excluding sections 4, 6) V1 042074 0026

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