BEUDAMED
    162 results · 20ms · Sources: EU EUDAMED, US FDA

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    ICS Impulse

    FDA 510(k)
    FDA Class 2 ·Neurology

    ICS Dizcovery (1091)

    FDA 510(k)
    FDA Class 2 ·Neurology

    ICS CHARTR EP 200 WITH VEMP

    FDA 510(k)
    FDA Class 2 ·Neurology

    1091, ICS Dizcovery LCD Panels

    Device
    EU MDR · Eu Md Class 1 ·Natus Medical Denmark ApS·On the market

    1091, ICS Dizcovery ShadeShift Panels

    Device
    EU MDR · Eu Md Class 1 ·Natus Medical Denmark ApS·On the market

    1091, ICS Dizcovery Universal Face Cushion (qty 40)

    Device
    EU MDR · Eu Md Class 1 ·Natus Medical Denmark ApS·On the market

    The ICS CHARTR EP 200

    FDA Enforcement
    Class II ·Terminated·GN Otometrics·October 30, 2019

    1091, ICS Dizcovery ShadeShift Panels

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Natus Medical Denmark ApS·3 devices

    XO CARE A/S

    Manufacturer
    🇩🇰 Denmark·5 Basic UDI-DIs·5 Devices·DNV Product Assurance AS and DNV Product Assurance AS

    NRT X-Ray A/S

    Manufacturer
    🇩🇰 Denmark·6 Basic UDI-DIs·6 Devices·DNV Product Assurance AS and DNV Product Assurance AS

    Cortrium ApS

    Manufacturer
    🇩🇰 Denmark·4 Basic UDI-DIs·4 Devices·TÜV SÜD Product Service GmbH and TÜV SÜD Product Service GmbH

    BIBAWO Medical A/S

    Manufacturer
    🇩🇰 Denmark·2 Basic UDI-DIs·4 Devices·DNV Product Assurance AS

    Cardia International A/S

    Manufacturer
    🇩🇰 Denmark·5 Basic UDI-DIs·5 Devices·IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.

    Hedia ApS

    Manufacturer
    🇩🇰 Denmark·1 Basic UDI-DI·1 Device·TÜV SÜD Product Service GmbH

    DDD-Diagnostic A/S

    Manufacturer
    🇩🇰 Denmark·6 Basic UDI-DIs·6 Devices·DNV Product Assurance AS

    MedArt ApS

    Manufacturer
    🇩🇰 Denmark·1 Basic UDI-DI·1 Device·GMED SAS

    Reapplix A/S

    Manufacturer
    🇩🇰 Denmark·1 Basic UDI-DI·1 Device·Eurofins Electric & Electronics Finland Oy

    G1 098327 0004

    Certificate
    MDD Annex II (excluding section 4)·Cortrium ApS·TÜV SÜD Product Service GmbH·1 Basic UDI-DI

    G1 098327 0004

    Certificate
    MDD Annex II (excluding section 4)·Cortrium ApS·TÜV SÜD Product Service GmbH·1 Basic UDI-DI

    C-01-1210-718-19

    Certificate
    MDD Annex II (excluding section 4)·Reapplix A/S·Eurofins Electric & Electronics Finland Oy·1 Basic UDI-DI