BEUDAMED
    2,412 results · 37ms · Sources: EU EUDAMED, US FDA

    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)

    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

    TRUPCR® Total Viral Nucleic Acid Extraction Kit (500µl)

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·3B BlackBio Dx Limited·1 device

    TRUPCR® BS DNA Extraction Kit

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·3B BlackBio Dx Limited·1 device

    TRUPCR® Panel Extraction Kit

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·3B BlackBio Dx Limited·1 device

    TRUPCR® BS DNA Extraction Kit

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·3B BlackBio Dx Limited·1 device

    TRUPCR® Total Viral Nucleic Acid Extraction Kit (500ul)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·3B BlackBio Dx Limited·1 device

    Analyzer, Medical Image

    FDA Pre-Market Approval
    FDA Class 2 ·IMAGECHECKER M5000, IMAGECHECKER M5000 DM, IMAGECHECKER M5000LX, IMAGECHECKER M5000 M5000 DX VERSION 8.0

    Permanent Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·TENDRIL DX, MODELS 1388 T/K & TENDRIL SDX MODELS 1488 T/K

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·LINOX SMART SD, VIGILA 1CR, VOLTA 1CR, LINOX SMART S DX, PROTEGO SD

    DEX SURGICAL

    System producer
    🇫🇷 France

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Acticor 7 VR-T, Rivacor 7 VR-T, Rivacor 5 VR, -T, Rivacor 3 VR-T, Acticor 7 VR-T DX, Rivacor 7 VR-T DX, Rivacor 5 VR-T D