BEUDAMED
    FDA Registration Active 🇺🇸 United States

    IS3

    Reg #: 3010185635 · FEI: 3010185635 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    HIOSSEN INC.
    Registration Number
    3010185635
    FEI Number
    3010185635
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    50 Maple Street
    City
    Norwood
    State
    NJ
    ZIP
    07648
    Country
    US

    Regulatory Submissions

    510(k) Number
    K180527

    Owner / Operator

    Firm Name
    Hiossen Inc.
    Operator Number
    10026425
    Address
    85 Ben Fairless Dr.
    City
    Fairless Hills
    State
    PA
    Postal Code
    19030
    Country
    US

    Products

    Device Name Product Code
    Handpiece, Direct Drive, Ac-Powered EKX

    Proprietary Names

    IS3

    Establishment Types

    Repack or Relabel Medical Device