BEUDAMED
    11 results · 9ms · Sources: EU EUDAMED, US FDA

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    Atomo Diagnostics Limited

    Manufacturer
    🇦🇺 Australia·2 Basic UDI-DIs·2 Devices·BSI Group The Netherlands B.V. and BSI Group The Netherlands B.V.

    ORAcollect (Swab based RNA Collection Device)

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·DNA Genotek Inc.·1 device

    ORAgene (Swab-based DNA & Dx Collection Device)

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·DNA Genotek Inc.·4 devices

    ORAcollect (Swab based DNA & Dx Collection Device)

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·DNA Genotek Inc.·3 devices

    Trueprep® AUTO v2 Universal Cartridge Based Sample Prep Device

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·Molbio Diagnostics Limited·1 device

    Simplitude ByMe

    Device
    EU IVDD · Eu Ivd Annex 2 List A ·Atomo Diagnostics Limited·On the market·7 countries

    Simplitude ByMe

    Device
    EU IVDD · Eu Ivd Annex 2 List A ·Atomo Diagnostics Limited·On the market·7 countries

    716015

    Certificate
    IVDD Annex IV Section 4·Atomo Diagnostics Limited·BSI Group The Netherlands B.V.·2 Basic UDI-DIs

    637070

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·Atomo Diagnostics Limited·BSI Group The Netherlands B.V.·2 Basic UDI-DIs

    HIV Self Test

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List A ·Atomo Diagnostics Limited·1 device

    HIV Self Test

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List A ·Atomo Diagnostics Limited·1 device