BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    Gengigel

    Reg #: 3005488671 · FEI: 3005488671 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SINERGA SPA
    Registration Number
    3005488671
    FEI Number
    3005488671
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Via Della Pacciarna 67
    City
    Gorla Maggiore Varese
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K053342

    Owner / Operator

    Firm Name
    SINERGA SPA
    Operator Number
    10092973
    Address
    Via della Pacciarna 67
    City
    Gorla Maggiore
    State
    Varese
    Postal Code
    21050
    Country
    IT

    US Agent

    Business Name
    GBM Authorized Representative Ltd.
    Contact Name
    James Martin Biggs
    Address
    10330 103rd St
    City
    Lexington
    State
    OK
    ZIP
    73051
    Country
    US
    Email
    [email protected]
    Phone
    405 7771033

    Products

    Device Name Product Code
    Oral Wound Dressing OLR

    Proprietary Names

    Gengigel

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)