BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Radiance Ultra 32" ZeroWire Embedded

    Reg #: 8043980 · FEI: 3002914049 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    W.O.M. WORLD OF MEDICINE GmbH
    Registration Number
    8043980
    FEI Number
    3002914049
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    ALTE POST STR. 11
    City
    LUDWIGSSTADT Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K161228

    Owner / Operator

    Firm Name
    W.O.M. WORLD OF MEDICINE GmbH
    Operator Number
    9004880
    Address
    Salzufer 8, --
    City
    Berlin
    State
    DE-NOTA
    Postal Code
    D-10587
    Country
    DE

    US Agent

    Business Name
    W.O.M. WORLD OF MEDICINE USA, INC
    Contact Name
    Aylin Ng Saye
    Address
    4531 36th Street
    City
    Orlando
    State
    FL
    ZIP
    32811
    Country
    US
    Email
    [email protected]
    Phone
    407 4388810

    Products

    Device Name Product Code
    Laparoscope, General & Plastic Surgery GCJ

    Proprietary Names

    Radiance Ultra 32" ZeroWire Embedded Radiance Ultra Series ZeroWire Embedded Radiance Ultra 27" ZeroWire Embedded Radiance Ultra 55" ZeroWire Embedded Radiance Ultra 24" ZeroWire Embedded

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)