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

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    VIDAS LYME IGM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MONOLISA ANTI-HAV IGM EIA

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ZYMUTEST HIA IgGAM. Model Number: RK040D. Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA isotypes by ELISA. 96 Tests.

    FDA Enforcement
    Class II ·Terminated·Hyphen BioMed·March 21, 2018

    ZYMUTEST HIA MonoStrip IgGAM. Model Number: RK041D. Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA isotypes by ELISA. 32 Tests.

    FDA Enforcement
    Class II ·Terminated·Hyphen BioMed·March 21, 2018

    ZYMUTEST HIA IgGAM; REF Number: RK040D; UDI: 03663537018770 a qualitative screening assay intended for the global detection of heparin- dependent antibodies, whether the isotype is: IgG, IgM and IgA, in human plasma, by clinical laboratories.

    FDA Enforcement
    Class II ·Terminated·Hyphen BioMed·May 16, 2018

    ZYMUTEST HIA MonoStria qualitative screening assay intended for the global detection of heparin-dependent antibodies, whether the isotype is: IgG, IgM and IgA, in human plasma, by clinical laboratories. p IgGAM; REF Number: RK041D; UDI: 03663537046810

    FDA Enforcement
    Class II ·Terminated·Hyphen BioMed·May 16, 2018

    IDMED

    FDA registration
    IDMED·3 products·🇫🇷 France

    IDROSTAR AXILLA

    Device
    EU MDD · Eu Md Class 2a ·Laboratoires I2M·On the market·2 countries

    IDROSTAR

    Device
    EU MDD · Eu Md Class 2a ·Laboratoires I2M·On the market·2 countries

    IDROSTAR PRO PULSE

    Device
    EU MDD · Eu Md Class 2a ·Laboratoires I2M·On the market·2 countries

    I2M.A

    Device
    EU MDD · Eu Md Class 2a ·Laboratoires I2M·On the market·2 countries

    IDROSTAR NT

    Device
    EU MDD · Eu Md Class 2a ·Laboratoires I2M·On the market·2 countries

    IDROSTAR AXILLA

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Laboratoires I2M·1 device

    IDROSTAR

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Laboratoires I2M·1 device

    IDROSTAR PRO PULSE

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Laboratoires I2M·1 device

    IDROSTAR NT

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Laboratoires I2M·1 device

    I2M.A

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Laboratoires I2M·1 device

    MANC-IRM-NI

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·ACIME FRAME·1 device

    SKIF-IRM-NI

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·ACIME FRAME·1 device

    ECM19MDD013

    Certificate
    MDD Annex II (excluding section 4)·Laboratoires I2M·ENTE CERTIFICAZIONE MACCHINE SRL·5 Basic UDI-DIs