BEUDAMED
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    Koios Medical Inc.

    Manufacturer
    🇺🇸 United States

    Koios Medical Inc.

    Manufacturer
    🇺🇸 United States·Intertek Medical Notified Body AB

    Koios Medical, Inc.

    FDA registration
    Koios Medical, Inc.·3 products·🇺🇸 United States

    Koios DS

    FDA UDI
    KOIOS MEDICAL, INC.·00860002545714·Koios Decision Support (DS) is a software appli...

    Koios Medical

    FDA UDI
    KOIOS MEDICAL, INC.·00860002545707·The Koios DS Breast system is designed to assis...

    Koios DS Breast . The device is a software application which assists skilled physicians in analyzing breast ultrasound images.

    FDA Recall
    Terminated ·Koios Medical, Inc.·Product code LLZ·December 31, 2019

    28620136087

    Certificate
    MDR QMS·Koios Medical Inc.·Intertek Medical Notified Body AB

    Koios DS Breast <series 1.0>. The device is a software application which assists skilled physicians in analyzing breast ultrasound images.

    FDA Enforcement
    Class II ·Terminated·Koios Medical, Inc.·January 29, 2020

    Emergo Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·900 Manufacturers·22100 Devices

    Obelis s.a.

    Authorized representative
    🇧🇪 Belgium·546 Manufacturers·18515 Devices

    VYGON

    Importer
    🇫🇷 France·26 Manufacturers