BEUDAMED
    FDA Registration Active 🇧🇬 Bulgaria

    Elysion Pro

    Reg #: 3016181563 · FEI: 3016181563 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Cocoon Medical International, Ltd
    Registration Number
    3016181563
    FEI Number
    3016181563
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    18A Parva Bulgarska Armia str
    City
    Sofia
    Country
    BG

    Regulatory Submissions

    510(k) Number
    K193367

    Owner / Operator

    Firm Name
    High Technology Products, SLU
    Operator Number
    10061761
    Address
    Carrer del Gall, 22
    City
    Esplugues de Llobregat
    State
    Barcelona
    Postal Code
    08950
    Country
    ES
    Correspondent
    Claudia Leite

    US Agent

    Business Name
    Freyr Inc
    Contact Name
    Shilpa Gampa
    Address
    150 COLLEGE ROAD WEST, SUITE 102
    City
    Princeton
    State
    NJ
    ZIP
    08540
    Country
    US
    Email
    [email protected]
    Phone
    760 5834401

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    Elysion Pro

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)