BEUDAMED
    139 results · 8ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Authorized Representative: Qb D Rep S Bv ×

    Atomo Diagnostics Limited

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

    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

    Shenzhen Superbio Technology Co.,Ltd.

    Manufacturer
    🇨🇳 China·589 Basic UDI-DIs·591 Devices·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

    Merlin Biomedical (Xiamen) Co., Ltd.

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

    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

    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.

    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

    BPR Medical Limited

    Manufacturer
    44 Basic UDI-DIs·44 Devices·3 Importers·SGS Belgium NV

    Yelatma Instrument-Making Enterprise Joint-Stock Company

    Manufacturer
    🇷🇺 Russian Federation·9 Basic UDI-DIs·20 Devices·TÜV NORD CERT GmbH

    1434-IVDD-254/2022

    Certificate
    IVDD Annex III Section 6·Shenzhen Superbio Technology Co.,Ltd.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·3 Basic UDI-DIs

    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

    2116232DE01

    Certificate
    MDD Annex II Section 4·MDT Int'l SA·DEKRA Certification B.V.·3 Basic UDI-DIs

    2116232DE02

    Certificate
    MDD Annex II Section 4·MDT Int'l SA·DEKRA Certification B.V.·2 Basic UDI-DIs

    GB19/964430

    Certificate
    MDD Annex II (excluding section 4)·BPR Medical Limited·SGS Belgium NV·44 Basic UDI-DIs

    44232117836

    Certificate
    MDD Annex II (excluding section 4)·Yelatma Instrument-Making Enterprise Joint-Stock Company·TÜV NORD CERT GmbH·6 Basic UDI-DIs

    QCT-0176-21

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

    2019-nCoV Antigen Rapid Test (Immunochromatography Assay)

    Device
    EU IVDD · Eu Ivd Self Testing ·Shenzhen Superbio Technology Co.,Ltd.·On the market