BEUDAMED
    9 results · 9ms · 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: Obelis S.A. ×

    HBV / HCV / HIV COMBINATION - MULTIPLEX NA REAGENTS

    Device
    EU IVDD · Eu Ivd Annex 2 List A ·Sanway Gene Tech. Inc.·On the market·3 countries

    HandX Needle Holder

    Device
    EU MDR · Eu Md Class 2a ·Human Xtensions Ltd.·On the market·5 countries

    HandX Handpiece

    Device
    EU MDR · Eu Md Class 2a ·Human Xtensions Ltd.·On the market·5 countries

    HandX Self- righting Needle Holder

    Device
    EU MDR · Eu Md Class 2a ·Human Xtensions Ltd.·On the market·5 countries

    Nucleic Acid Test Kit for HBV, HCV, HIV (Type1+2) (Real-time PCR)

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List A ·Sanway Gene Tech. Inc.·1 device

    HandX Needle Holder

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·Human Xtensions Ltd.·2 devices

    HandX Handpiece

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·Human Xtensions Ltd.·1 device

    1434-IVDD-198/2022

    Certificate
    IVDD Annex IV Section 4·Sanway Gene Tech. Inc.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI

    1434-IVDD-199/2022

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·Sanway Gene Tech. Inc.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI