BEUDAMED
    FDA Registration Active 🇫🇷 France

    Winback

    Reg #: 3022747124 · FEI: 3022747124 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    WINBACK EUROPA SAS
    Registration Number
    3022747124
    FEI Number
    3022747124
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    20 Avenue Victor Hugo
    City
    Biarritz Nouvelle-Aquitaine
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K214090

    Owner / Operator

    Firm Name
    Swims SAS
    Operator Number
    10085110
    Address
    Les Bureaux du Parc
    City
    Villeneuve Loubet
    State
    Alpes-Maritimes
    Postal Code
    06270
    Country
    FR
    Correspondent
    Clemence Roux

    US Agent

    Business Name
    SWIMS America
    Contact Name
    Matthieu Commeau
    Address
    1133 Westchester Avenue Suite 220
    City
    East White Plains
    State
    NY
    ZIP
    10604
    Country
    US
    Email
    [email protected]
    Phone
    917 3717388

    Products

    Device Name Product Code
    Massager, Vacuum, Radio Frequency Induced Heat PBX

    Proprietary Names

    Winback

    Establishment Types

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