BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    Initial One

    Reg #: 3003775534 · FEI: 3003775534 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    17
    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
    K040567

    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
    Powder, Porcelain EIH

    Proprietary Names

    Initial One Initial Initial Lustre Pastes NF Initial IQ Initial LiSi Initial Spectrum Stains Initial PC Initial TI Initial IQ SQIN Initial Lustre Paste One Creation ZI-CT, ZI-F Creation Magic Colour Lisi PressVest Creation Creation CC Creation LS Initial Brush

    Establishment Types

    Manufacture Medical Device