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: Med Envoy Global Bv ×

    SpeeDx Pty. Ltd.

    Manufacturer
    🇦🇺 Australia·1 Basic UDI-DI·3 Devices·1 Importer

    Juvora Limited

    Manufacturer
    SGS Belgium NV

    Echo Electricity Co., Ltd

    Manufacturer
    🇯🇵 Japan·SGS Belgium NV

    PlexPCR RespiVirus (610)

    Device
    EU IVDR · Eu Ivd Class B ·SpeeDx Pty. Ltd.·On the market·1 country

    PlexPCR RespiVirus Positive Control

    Device
    EU IVDR · Eu Ivd Class B ·SpeeDx Pty. Ltd.·On the market·32 countries

    PlexPCR RespiVirus (610)

    Device
    EU IVDR · Eu Ivd Class B ·SpeeDx Pty. Ltd.·On the market·7 countries

    PlexPCR RespiVirus

    Basic UDI-DI
    EU IVDR · Eu Ivd Class B ·SpeeDx Pty. Ltd.·3 devices

    JP24/00000218

    Certificate
    MDR QA·Echo Electricity Co., Ltd·SGS Belgium NV

    GB23/00000417

    Certificate
    MDR QMS·Juvora Limited·SGS Belgium NV