BEUDAMED
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    nordicBrainEX Product Usage: nordicBrainEx is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform image viewing, processing and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities.

    FDA Enforcement
    Class II ·Terminated·NordicNeuroLab AS·June 6, 2018

    VitalThings AS

    Manufacturer
    🇳🇴 Norway·SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ

    Augere Medical AS

    Manufacturer
    🇳🇴 Norway·Kiwa Dare B.V.

    21M00170CRT01

    Certificate
    MDR QMS·Augere Medical AS·Kiwa Dare B.V.

    MDR-0017

    Certificate
    MDR QMS·VitalThings AS·SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ