BEUDAMED
    FDA Registration Active 🇺🇸 United States

    F CARE SYSTEMS USA

    Reg #: 3008816935 · FEI: 3009438986 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    F CARE SYSTEMS USA
    Registration Number
    3008816935
    FEI Number
    3009438986
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    755 NE 164TH TERRACE
    City
    Miami
    State
    FL
    ZIP
    33162
    Country
    US

    Regulatory Submissions

    510(k) Number
    K130283

    Owner / Operator

    Firm Name
    F CARE SYSTEMS USA
    Operator Number
    10035152
    Address
    11098 BISCAYNE BLVD, SUITE 301
    City
    Miami
    State
    FL
    Postal Code
    33161
    Country
    US
    Correspondent
    PATRICK DANCIU

    Products

    Device Name Product Code
    Catheter, Pediatric, General & Plastic Surgery GBN
    Electrosurgical Coagulation For Aesthetic ONQ
    Catheter, Intravascular Occluding, Temporary MJN
    Electrosurgical, Cutting & Coagulation & Accessories GEI

    Proprietary Names

    SUPER SETON EVRF THERMAVEIN VIRIDEX KAVS MED RF 4000 RAFAELO CATHETER HPR HPR 45i

    Establishment Types

    Repack or Relabel Medical Device