BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    ULTRASUN

    Reg #: 9680413 · FEI: 3004531930 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    14
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    ULTRASUN
    Registration Number
    9680413
    FEI Number
    3004531930
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    GRANAATSTRAAT 6
    City
    HENGELO Overijssel
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K210004

    Owner / Operator

    Firm Name
    Ultrasun International B.V.
    Operator Number
    9008844
    Address
    Granaatstraat 6
    City
    Hengelo
    State
    Overijssel
    Postal Code
    7554 TR
    Country
    NL

    US Agent

    Business Name
    Bentley Biomedical Consulting, LLC
    Contact Name
    Shepard Bentley
    Address
    29461 Troon St
    City
    Laguna Niguel
    State
    CA
    ZIP
    92677
    Country
    US
    Email
    [email protected]
    Phone
    949 3749187

    Products

    Device Name Product Code
    Light, Ultraviolet, Dermatological FTC
    Booth, Sun Tan LEJ
    Exerciser, Powered BXB
    Disinfectant, Medical Devices LRJ

    Proprietary Names

    Q18 i8 E6 UltraSun I8 Q14 Q6-0 Q6-2 Q10 i9 Q22 SunFit Lamp DR MUELLER COLLASHOWER 48 WITH VIBRAPLATE UltraSun Air Filter UltraSun Sunbed

    Establishment Types

    Manufacture Medical Device