BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    Medi Lift Essential Eye Mask

    FDA 510(k)
    FDA Class 2 ·Neurology

    AUTION EYE AI-4510 Urine Particle Analysis System

    FDA 510(k)
    FDA Class 2 ·Hematology

    AUTION EYE Calibrator

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·1 device

    Eye-Tracking Perimeter FIELDNavigator

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·FINDEX Inc.·1 device

    AUTION EYE Sheath Solution

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·8 devices

    AUTION EYE Sheath Solution

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·1 device

    AUTION EYE Control Solution

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·1 device

    AUTION EYE (AI-4510)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·1 device

    Canon Full Auto Ref-Keratometer RK-F2, Catalog Number 6937B002AA. Product Usage: This device is intended to be used to measure the refractive power and the radius of corneal curvature of the human eye.

    FDA Enforcement
    Class II ·Terminated·Canon Inc.·June 5, 2013