BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    HPR45i

    Reg #: 3008264458 · FEI: 3008264458 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    FCARE SYSTEMS NV
    Registration Number
    3008264458
    FEI Number
    3008264458
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Uitbreidingstraat 42-46
    City
    Berchem Antwerpen
    Country
    BE

    Regulatory Submissions

    510(k) Number
    K220725

    Owner / Operator

    Firm Name
    fcare Systems NV
    Operator Number
    10043355
    Address
    Uitbreidingstraat 42-46
    City
    Berchem
    State
    Antwerpen
    Postal Code
    2600
    Country
    BE
    Correspondent
    Rudi Devers

    US Agent

    Business Name
    F Care Systems USA LLc
    Contact Name
    Patrick Danciu
    Address
    755 Ne 164th Ter
    City
    Miami
    State
    FL
    ZIP
    33162
    Country
    US
    Email
    [email protected]
    Phone
    786 2880740

    Products

    Device Name Product Code
    Electrosurgical, Cutting & Coagulation & Accessories GEI

    Proprietary Names

    HPR45i

    Establishment Types

    Manufacture Medical Device