BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    FIAB SPA

    Reg #: 3003072803 · FEI: 3003072803 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    26
    Establishment Types
    2
    Classifications
    7

    Registration Details

    Registration Name
    FIAB SPA
    Registration Number
    3003072803
    FEI Number
    3003072803
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Via Costoli, 4
    City
    Vicchio Firenze
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K192210

    Owner / Operator

    Firm Name
    Fiab SpA
    Operator Number
    10027015
    Address
    Via Costoli 4
    City
    Vicchio
    State
    Firenze
    Postal Code
    50039
    Country
    IT

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Dr
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Cable, Electrode IKD
    Continuous Measurement Thermometer FLL
    Dc-Defibrillator, Low-Energy, (Including Paddles) LDD
    Unit, Cautery, Thermal, Battery-Powered HQP
    Electrode, Electrocardiograph DRX
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Electrode, Cutaneous GXY

    Proprietary Names

    30115 Esotest Multi Monitor 2615358H/US Esotest Multi Probe 5 sensors F5417/US Esotest Multi Patient Cable 2617376H/US Esotest Multi Probe 7 sensors F7817TPM70/30/US Esotest Multi Adapter Cable Sensitherm Multi Monitor ST-MONITOR Sensitherm Multi Patient Cable ST-PTCBL Sensitherm Multi Adapter ST-ADPT-30 Sensitherm Multi Probe ST-PROBE-5 Sensitherm Multi Probe ST-PROBE-7 FIAB ESOTEST MULTI PATIENT CABLE FIAB ESOTEST MULTI MONITOR FIAB ESOTEST MULTI PROBE FIAB ESOTEST MONITOR, ESOTEST ULTRA FIAB F5406/TER, F5406/ULTRA INTERCONNECT CABLE FIAB ESOTEST PROBE FIAB EURO DEFI PADS FIAB Low Temperatory cautery FIAB ECG PATIENT CABLE FIAB SNAP CONNECTION CABLE FIAB ECG ELECTRODES FIAB ECG ACCESSORIES FIAB High temperature cautery DISPOSABLE FULLY GELLEDE NEUROSTIMULATION ELECTRODES WITH SNAP DISPOSABLE FULLY GELLEDE NEUROSTIMULATION ELECTRODES WITH CABLE FIAB ELECTRODES

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device