BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    DEKA LUXEA

    Reg #: 3001431138 · FEI: 3001431138 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    EL.EN. ELECTRONIC ENGINEERING SPA
    Registration Number
    3001431138
    FEI Number
    3001431138
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    17 VIA BALDANZESE
    City
    CALENZANO Firenze
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K192539

    Owner / Operator

    Firm Name
    EL.EN. ELECTRONIC ENGINEERING SPA
    Operator Number
    9057711
    Address
    VIA BALDANZESE 17, --
    City
    CALENZANO
    State
    Firenze
    Postal Code
    50041
    Country
    IT
    Correspondent
    PAOLO - PERUZZI

    US Agent

    Business Name
    Emergo Global Consulting LLC
    Contact Name
    Greg Swanson
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

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

    Proprietary Names

    DEKA LUXEA DEKA TRUIST

    Establishment Types

    Manufacture Medical Device