BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    GripMate

    Reg #: 3038138498 · FEI: 3038138498 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SYNTHON B.V.
    Registration Number
    3038138498
    FEI Number
    3038138498
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Microweg 22
    City
    Nijmegen Gelderland
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K243232

    Owner / Operator

    Firm Name
    Synthon B.V.
    Operator Number
    10092950
    Address
    Microweg 22
    City
    Nijmegen
    State
    Gelderland
    Postal Code
    6545
    Country
    NL
    Correspondent
    Virginia Lopez

    US Agent

    Business Name
    Lachman Consultant Services, Inc.
    Contact Name
    Rebecca (Becky) Welton
    Address
    1600 Stewart Ave
    City
    Westbury
    State
    NY
    ZIP
    11590
    Country
    US
    Email
    [email protected]
    Phone
    516 2226222

    Products

    Device Name Product Code
    Introducer, Syringe Needle KZH

    Proprietary Names

    GripMate

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device