BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    FUJI I

    Reg #: 3003775534 · FEI: 3003775534 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GC EUROPE N.V.
    Registration Number
    3003775534
    FEI Number
    3003775534
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Researchpark Haasrode - Leuven 1240, Interleuvenlaan 33
    City
    LEUVEN Vlaams Brabant
    Country
    BE

    Regulatory Submissions

    510(k) Number
    K980695

    Owner / Operator

    Firm Name
    GC America Inc.
    Operator Number
    8030268
    Address
    3737 W. 127th Street
    City
    Alsip
    State
    IL
    Postal Code
    60803
    Country
    US
    Correspondent
    Futoshi Fusejima

    US Agent

    Business Name
    GC America Inc.
    Contact Name
    Futoshi Fusejima
    Address
    3737 W 127th St
    City
    Alsip
    State
    IL
    ZIP
    60803
    Country
    US
    Email
    [email protected]
    Phone
    708 9263050

    Products

    Device Name Product Code
    Cement, Dental EMA

    Proprietary Names

    FUJI I

    Establishment Types

    Repack or Relabel Medical Device