BEUDAMED
    4,426 results · 38ms · Sources: EU EUDAMED, US FDA

    hybcell Bacteria DNA xB

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Cube Dx GmbH·1 device

    hybcell Fungi DNA xB

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Cube Dx GmbH·1 device

    hybcell Pathogens DNA xB

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Cube Dx GmbH·1 device

    PCR-Box Bacteria

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Cube Dx GmbH·1 device

    PCR-Box Fungi

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Cube Dx GmbH·1 device

    PCR-Box Resistance

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Cube Dx GmbH·1 device

    LINA

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Cube Dx GmbH·1 device

    IPC

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Cube Dx GmbH·1 device

    GINA 500

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Cube Dx GmbH·1 device

    GINA 500 + DNA purification

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Cube Dx GmbH·1 device

    PCR-Box IPC

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Cube Dx GmbH·1 device

    hyborg Dx RED2

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·Cube Dx GmbH·5 devices

    Hydropump

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·DX Products Limited·45 devices

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·CARELINK MONITORS, CARELINK EXPRESS MONITIORS, CARDIOSIGHT READERS, REVEAL DX, REVEAL XT

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA)

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA)

    Permanent Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·ISOFLEX S PERMANENT PACING LEAD MODELS

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Ilivia Neo 7 VR-T, Intica Neo 7 and 5 VR-T, Ilivia Neo 7 VR-T DX, and Intica Neo 7 and 5 VR-T DX

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Ilivia Neo 7 VR-T DX, Ilivia Neo 7 VR-T, Intica Neo 7 VR-T, Intica Neo 5 VR-T DX, Intica Neo 5 VR-T

    TRUPCR® Bacterial / Fungal DNA Extraction Kit

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·3B BlackBio Dx Limited·2 devices