BEUDAMED
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    ORAGENE DX OGD-500.001

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    GenomeMe Lab Inc.

    Manufacturer
    🇨🇦 Canada·2 Importers

    ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MetaOptima Technology Inc.

    Manufacturer
    🇨🇦 Canada·1 Importer

    bioLytical Laboratories Inc.

    Manufacturer
    🇨🇦 Canada·38 Basic UDI-DIs·38 Devices·Presafe Denmark A/S, Presafe Denmark A/S, Presafe Denmark A/S, Presafe Denmark A/S, and Presafe Denmark A/S

    DNA Genotek Inc.

    Manufacturer
    🇨🇦 Canada·10 Basic UDI-DIs·31 Devices·5 Importers

    M200-M/QD

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Beyes Dental Canada Inc·1 device

    INSTI HIV Self Test

    Device
    EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·On the market·32 countries

    INSTI HIV-1/HIV-2 ANTIBODY TEST KIT

    Device
    EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·On the market·32 countries

    INSTI HIV-1/HIV-2 Antibody Test

    Device
    EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·On the market·32 countries

    iSTATIS COVID-19 Ag HOME TEST

    Device
    EU IVDD · Eu Ivd General ·bioLytical Laboratories Inc.·On the market·32 countries

    iSTATIS COVID-19 Ag HOME TEST

    Device
    EU IVDD · Eu Ivd General ·bioLytical Laboratories Inc.·On the market·32 countries

    iSTATIS COVID-19 Ag TEST

    Device
    EU IVDD · Eu Ivd General ·bioLytical Laboratories Inc.·On the market·32 countries

    INSTI COVID ANTIBODY TEST

    Device
    EU IVDD · Eu Ivd General ·bioLytical Laboratories Inc.·On the market·32 countries

    INSTI HIV ANTIBODY SELF-TEST

    Device
    EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·On the market·32 countries

    INSTI HCV CONTROL TEST KIT

    Device
    EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·On the market·32 countries

    INSTI HIV ANTIBODY SELF-TEST

    Device
    EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·On the market·32 countries

    INSTI HCV ANTIBODY TEST KIT

    Device
    EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·On the market·32 countries

    INSTI HCV ANTIBODY TEST KIT

    Device
    EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·On the market·32 countries

    INSTI HCV ANTIBODY TEST KIT

    Device
    EU IVDD · Eu Ivd Annex 2 List A ·bioLytical Laboratories Inc.·On the market·32 countries