BEUDAMED
    FDA Registration Active 🇫🇷 France

    CoLink Plating System

    Reg #: 1000461041 · FEI: 1000461041 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SELENIUM MEDICAL S.A.S.
    Registration Number
    1000461041
    FEI Number
    1000461041
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    9049 Rue de Quebec
    City
    La Rochelle Charente-Maritime
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K163293

    Owner / Operator

    Firm Name
    Selenium Medical S.A.S.
    Operator Number
    10045214
    Address
    9049 Rue de Quebec
    City
    La Rochelle
    State
    Charente-Maritime
    Postal Code
    17000
    Country
    FR

    US Agent

    Business Name
    DAWA MEDICAL LLC
    Contact Name
    Stephan TOUPIN
    Address
    7320 NW, 12th street suite 103
    City
    Miami
    State
    FL
    ZIP
    33126
    Country
    US
    Email
    [email protected]
    Phone
    786 7311159

    Products

    Device Name Product Code
    Plate, Fixation, Bone HRS
    Screw, Fixation, Bone HWC

    Proprietary Names

    CoLink Plating System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)