BEUDAMED
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    MDT Int'l SA

    Manufacturer
    🇨🇭 Switzerland·7 Basic UDI-DIs·7 Devices·1 Importer·ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', DEKRA Certification B.V., and DEKRA Certification B.V.

    TRUD

    Device
    EU MDD · Eu Md Class 2a ·MDT Int'l SA·On the market·4 countries

    GAF

    Device
    EU MDD · Eu Md Class 3 ·MDT Int'l SA·On the market·2 countries

    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

    TRUD

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·MDT Int'l SA·1 device

    GAF

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·MDT Int'l SA·1 device

    QPZ-01910-18

    Certificate
    MDD Annex V·MDT Int'l SA·ISTITUTO SUPERIORE DI SANITA'·1 Basic UDI-DI

    QCT-0176-21

    Certificate
    MDD Annex II (excluding section 4)·MDT Int'l SA·ISTITUTO SUPERIORE DI SANITA'·1 Basic UDI-DI

    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