BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    mariPOC® CDI test plate

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·ArcDia International Oy Ltd·1 device

    Orthopantomograph OP300 dental computed tomography x-ray system. The X-ray device produces conventional 2D X-ray images and Xray projection images for the reconstruction of a 3D view. The device is operated and used by qualified healthcare professionals.

    FDA Enforcement
    Class II ·Ongoing·Palodex Group Oy·August 21, 2024

    mariPOC® Gastro CDI combi test plate

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·ArcDia International Oy Ltd·1 device

    Co-Test Finland Oy

    Importer
    🇫🇮 Finland·4 Manufacturers

    FD-3600

    Basic UDI-DI
    EU MDD · Eu Md Class 1 ·Finndent Oy·1 device

    FD-5000

    Basic UDI-DI
    EU MDD · Eu Md Class 1 ·Finndent Oy·1 device

    FD-8000

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Finndent Oy·1 device

    FD-Q

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Finndent Oy·1 device

    Elers Medical Finland Oy

    Importer
    🇫🇮 Finland·6 Manufacturers