BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    GripMate

    Reg #: 3002958688 · FEI: 3002958688 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ENESTIA BELGIUM NV (SHARP BELGIUM)
    Registration Number
    3002958688
    FEI Number
    3002958688
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Klocknerstraat 1
    City
    Hamont-Achel Limburg
    Country
    BE

    Regulatory Submissions

    510(k) Number
    K243232

    Owner / Operator

    Firm Name
    Enestia Belgium NV (Sharp Belgium)
    Operator Number
    10093022
    Address
    Klocknerstraat 1
    City
    Hamont-Achel
    State
    Limburg
    Postal Code
    3930
    Country
    BE
    Correspondent
    Anouk Haselaars

    US Agent

    Business Name
    Sharp Packaging Services, LLC
    Contact Name
    Margaret Grace Breen
    Address
    7451 Keebler Way
    City
    Allentown
    State
    PA
    ZIP
    18106
    Country
    US
    Email
    [email protected]
    Phone
    484 8660113

    Products

    Device Name Product Code
    Introducer, Syringe Needle KZH

    Proprietary Names

    GripMate

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)