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

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    Filters Country: France ×

    FCI SAS

    FDA registration
    FCI SAS·30 products·🇫🇷 France

    FCI FRANCE CHIRURGIE INSTRUMENTATION

    FDA registration
    FCI FRANCE CHIRURGIE INSTRUMENTATION·31 products·🇫🇷 France

    Withings ECG Monitor

    Device
    EU MDR · Eu Md Class 2a ·Withings·On the market·31 countries

    Câble ECG 5 brins Thorax Gris (CHC)

    Device
    EU MDR · Eu Md Class 1 ·NOVACOR·On the market·10 countries

    Câble ECG 5 brins Standard Gris (CHB)

    Device
    EU MDR · Eu Md Class 1 ·NOVACOR·On the market·10 countries

    Reusable ECG Cables

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·NISSHA MEDICAL TECHNOLOGIES SAS·4 devices

    Reusable ECG Cables

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·NISSHA MEDICAL TECHNOLOGIES SAS·2 devices

    Withings ECG Monitor

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·Withings·1 device

    ILR ECG Analyzer

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

    Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen saturation (SpO2)

    FDA Enforcement
    Class II ·Ongoing·Withings·March 29, 2023

    CG MEDICAL

    System producer
    🇫🇷 France

    France Chirurgie Instrumentation SAS (FCI S.A.S.)

    System producer
    🇫🇷 France