BEUDAMED
    7,363 results · 53ms · Sources: EU EUDAMED, US FDA

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    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·ZOOM LATITUDE PROGRAMMER

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·FreeStyle Libre Pro Flash Glucose Monitoring System

    Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

    FDA Pre-Market Approval
    FDA Class 3 ·Freestyle Libre Flash Glucose Monitoring System

    Blackstone

    Authorized representative
    🇸🇮 Slovenia·1 Manufacturer

    Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

    FDA Pre-Market Approval
    FDA Class 3 ·Freestyle Libre Flash Glucose Monitoring System; FreeStyle Libre 14 Day Flash Glucose Monitoring System

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    FDA Pre-Market Approval
    FDA Class 3 ·Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), leads, extensions, and accessories

    Dorsal Root Ganglion Stimulator For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Dorsal Root Ganglion Stimulation (DRG) Implantable Pulse Generators (IPGs), leads, extensions, and accessories

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Senza Spinal Cord Stimulation (SCS) System, Senza HFX iQ System

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), leads, extensions, and accessories

    Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

    FDA Pre-Market Approval
    FDA Class 3 ·Freestyle Libre 14 day Flash Glucose Monitoring System

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·FreeStyle Libre Pro Flash Glucose Monitoring System

    IVKO GmbH

    Authorized representative
    🇩🇪 Germany

    OKO SOLUTION

    Authorized representative
    🇫🇷 France·2 Manufacturers·44 Devices

    Eruditio - Sensuum

    Importer
    🇧🇪 Belgium·1 Manufacturer

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·FREESTYLE LIBRE PRO FLASH GLUCOSE MONITORING SYSTEM

    Shunt, Portosystemic, Endoprosthesis

    FDA Pre-Market Approval
    FDA Class 3 ·Gore Viatorr TIPS

    2204C04210402

    Certificate
    MDD Annex II (excluding section 4)·ISO Med·HTCert (Health Technology Certification Ltd)·6 Basic UDI-DIs

    Uriki Test K

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

    URIKI BOARD

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

    Uriki

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·Iki·1 device