BEUDAMED
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    GA-map® Sample Collection Kit

    Device
    EU IVDR · Eu Ivd Class A ·Genetic Analysis AS·On the market·32 countries

    GA-map® Dysbiosis Test Lx v2

    Device
    EU IVDD · Eu Ivd General ·Genetic Analysis AS·On the market

    GA-map® COVID-19 Fecal Test Kit

    Device
    EU IVDD · Eu Ivd General ·Genetic Analysis AS·On the market·1 country

    VINGMED SOUND COLOR FLOW MAPPING SYSTEM, CFM-800

    FDA 510(k)
    FDA Class 2 ·Radiology

    nordicICE v 2.3.14 nordicICE 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. nordicICE provides both viewing and analysis capabilities of functional and dynamic imaging datasets acquired with MRI or other relevant modalities, including blood oxygen level dependent (BOLD) fMRI, diffusion weighted MRI (DWI) / fiber tracking and dynamic analysis.

    FDA Enforcement
    Class II ·Terminated·NordicNeuroLab AS·June 13, 2018

    GA-map® Sample Collection Kit

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·Genetic Analysis AS·1 device

    GA-map® Dysbiosis Test Lx v2

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Genetic Analysis AS·1 device

    GA-map® COVID-19 Fecal Test Kit

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Genetic Analysis AS·1 device