BEUDAMED
    7 results · 11ms · 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: Emergo Europe B.V. ×

    Infraredx, Inc.

    Manufacturer
    🇺🇸 United States·2 Basic UDI-DIs·2 Devices·1 Importer·BSI Group The Netherlands B.V. and BSI Group The Netherlands B.V.

    Dualpro™ IVUS+NIRS Imaging Catheter

    Device
    EU MDD · Eu Md Class 3 ·Infraredx, Inc.·On the market·16 countries

    Makoto Intravascular Imaging System™

    Device
    EU MDD · Eu Md Class 2a ·Infraredx, Inc.·On the market·16 countries

    Makoto Intravascular Imaging System™

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Infraredx, Inc.·1 device

    Dualpro™ IVUS+NIRS Imaging Catheter

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·Infraredx, Inc.·1 device

    670602

    Certificate
    MDD Annex II (excluding section 4)·Infraredx, Inc.·BSI Group The Netherlands B.V.·1 Basic UDI-DI

    670605

    Certificate
    MDD Annex II Section 4·Infraredx, Inc.·BSI Group The Netherlands B.V.·1 Basic UDI-DI