BEUDAMED
    73 results · 17ms · Sources: EU EUDAMED, US FDA

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    3mensio Workstation (Vascular Fenestrated) software

    FDA Enforcement
    Class II ·Ongoing·PIE Medical Imaging B.V.·August 20, 2025

    G1 098021 0005

    Certificate
    MDD Annex II (excluding section 4)·Pie Medical Imaging B.V.·TÜV SÜD Product Service GmbH·23 Basic UDI-DIs

    db-die Beraterapotheke B.V.

    Importer
    🇳🇱 Netherlands·1 Manufacturer

    Clean Quick Viral

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·CleanNA B.V.·2 devices

    CMV Brite Turbo kit

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List B ·IQ Products BV·1 device

    CleanNGS Dx

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·CleanNA B.V.·2 devices

    PathoNostics Color Calibration kit

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·PathoNostics B.V.·1 device

    CeliaSCAN

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Microbe&Lab B.V.·1 device

    PathoNostics Extraction kit

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·PathoNostics B.V.·1 device

    Universal Color Compensation kit

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·PathoNostics B.V.·1 device

    2SMARTFinder Color Compensation

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·PathoFinder B.V.·1 device

    HITAlert Kit

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·IQ Products BV·1 device

    FMH QuikQuant

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·IQ Products BV·1 device

    RealAccurate® Quadruplex Color Compensation v5

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·PathoFinder B.V.·1 device

    Fetal Cell Count Kit

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·IQ Products BV·1 device

    Cortisol & Cortisone Reagent Set

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List B ·Diagnotix B.V.·1 device

    DermaGenius® 3.0 Nail Multiplex real-time PCR kit

    Basic UDI-DI
    EU IVDR · Eu Ivd Class B ·PathoNostics B.V.·1 device

    CCF-D0384

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·CleanNA B.V.·1 device

    Cystic Fibrosis Transmembrane Conductance Regulator Gene (CFTR) Library Prep Kit for Illumina®

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·NimaGen BV·1 device

    Breast Cancer 1 (BRCA1) and Breast Cancer 2 (BRCA2) Library Prep Kit for Illumina®

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·NimaGen BV·1 device