BEUDAMED
    Eu Mdd Eu Md Class 2a On The Market 🇨🇳 China

    OPHTHALMIC DEVICES - OTHER

    Shenzhen CERTAINN Technology Co., Ltd. · 🇨🇳 China
    View on EUDAMED
    Devices (same UDI-DI)
    1
    Certificates
    1
    Countries
    1
    Notified Bodies
    1

    Basic Information

    Primary DI
    D-CNMF000016915YKAA6V
    Basic UDI-DI Code
    B-CNMF000016915YKAA6V
    Reference
    507CP0002/507CP1001/508CP0003/510CP0001
    Device Types
    None provided
    Regulation
    Eu Mdd
    Classification
    Eu Md Class 2a
    Status
    On The Market
    Manufacturer
    Shenzhen CERTAINN Technology Co., Ltd.

    Additional Description

    The OCT is a non-contact, high resolution tomographic and bio microscopic imaging device. It is indicated for in-vivo viewing, axial cross-sectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures, including cornea, retina, retinal nerve fiber layer, macula, and optic disc. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, age-related macular degeneration, and glaucoma.

    CND Nomenclature Codes

    Code Description
    Q0299 OPHTHALMIC DEVICES - OTHER

    Certificates

    Type Number
    MDD Annex II (excluding section 4) G10869200010

    Available In Countries

    🇬🇷 Greece

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