BEUDAMED
    FDA Registration Active 🇪🇸 Spain

    GripMate

    Reg #: 3004837462 · FEI: 3004837462 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    SYNTHON HISPANIA S.L.
    Registration Number
    3004837462
    FEI Number
    3004837462
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    CALLE Castello, 1 - PG SALINAS
    City
    Sant Boi de Llobregat Barcelona
    Country
    ES

    Regulatory Submissions

    510(k) Number
    K243232

    Owner / Operator

    Firm Name
    Synthon Hispania S.L.
    Operator Number
    10092498
    Address
    Castello 1
    City
    Sant Boi de Llobregat
    State
    Barcelona
    Postal Code
    08830
    Country
    ES
    Correspondent
    Ana Miralles

    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

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device