BEUDAMED
    FDA Registration Active 🇫🇷 France

    E>EYE

    Reg #: 3014132468 · FEI: 3014132468 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    E-SWIN
    Registration Number
    3014132468
    FEI Number
    3014132468
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    ZA de la Prevote, Rue des Cotes d'Orval
    City
    Houdan Yvelines
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K200616

    Owner / Operator

    Firm Name
    E-Swin
    Operator Number
    10076601
    Address
    ZA de la Prevote, Rue des Cotes d'Orval
    City
    Houdan
    State
    Yvelines
    Postal Code
    78550
    Country
    FR

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX
    Powered Light Based Non-Laser Surgical Instrument With Thermal Effect ONF
    Powered Laser Surgical Instrument With MicrobeamFractional Output ONG

    Proprietary Names

    E>EYE E>EYE C

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198