BEUDAMED
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    GE Healthcare Japan Corporation

    Manufacturer
    🇯🇵 Japan·4 Basic UDI-DIs·8 Devices

    EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A)

    FDA 510(k)
    FDA Class 2 ·Neurology

    AE-120A EEG Head Set

    FDA 510(k)
    FDA Class 2 ·Neurology

    Nihon Kohden QP-160AK EEG Trend Program

    FDA 510(k)
    FDA Class 2 ·Neurology

    Elefix V Paste for EEG & EMG

    FDA 510(k)
    FDA Class 2 ·Neurology

    SmartMAR

    Device
    EU MDR · Eu Md Class 2a ·GE Healthcare Japan Corporation·On the market·32 countries

    ASiR-V

    Device
    EU MDR · Eu Md Class 2a ·GE Healthcare Japan Corporation·On the market·32 countries

    Revolution Ascend Elite

    Device
    EU MDR · Eu Md Class 2b ·GE Healthcare Japan Corporation·On the market·32 countries

    Revolution Ascend Plus

    Device
    EU MDR · Eu Md Class 2b ·GE Healthcare Japan Corporation·On the market·32 countries

    Revolution Ascend Select

    Device
    EU MDR · Eu Md Class 2b ·GE Healthcare Japan Corporation·On the market·32 countries

    Deep Learning Image Reconstruction

    Device
    EU MDR · Eu Md Class 2a ·GE Healthcare Japan Corporation·On the market·32 countries

    Deep Learning Image Reconstruction

    Device
    EU MDR · Eu Md Class 2a ·GE Healthcare Japan Corporation·On the market·32 countries

    Revolution Ascend

    Device
    EU MDR · Eu Md Class 2b ·GE Healthcare Japan Corporation·On the market·32 countries

    Deep Learning Image Reconstruction

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·GE Healthcare Japan Corporation·2 devices

    SmartMAR

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·GE Healthcare Japan Corporation·1 device

    ASiR-V

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·GE Healthcare Japan Corporation·1 device

    Revolution Ascend

    Basic UDI-DI
    EU MDR · Eu Md Class 2b ·GE Healthcare Japan Corporation·4 devices