BEUDAMED
    11 results · 10ms · 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.

    Merlin Biomedical (Xiamen) Co., Ltd.

    Manufacturer
    🇨🇳 China·1 Basic UDI-DI·1 Device·CeCert Sp. z o.o.

    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

    SARS-CoV-2 Antigen Rapid Test Cassette

    Device
    EU IVDD · Eu Ivd Self Testing ·Merlin Biomedical (Xiamen) Co., Ltd.·On the market

    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

    CeCert/037/W/E.1

    Certificate
    IVDD Annex III Section 6·Merlin Biomedical (Xiamen) Co., Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI

    SARS-CoV-2 Antigen Rapid Test Cassette

    Basic UDI-DI
    EU IVDD · Eu Ivd Self Testing ·Merlin Biomedical (Xiamen) Co., Ltd.·1 device