BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    FOGLESS INTERNATIONAL AB

    Reg #: 3014054118 · FEI: 3014054118 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    FOGLESS INTERNATIONAL AB
    Registration Number
    3014054118
    FEI Number
    3014054118
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Storgatan 24
    City
    Vaggeryd Jonkoping
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K122932

    Owner / Operator

    Firm Name
    Fogless International AB
    Operator Number
    10055703
    Address
    Storgatan 24
    City
    Vaggeryd
    State
    Jonkoping
    Postal Code
    SE567 32
    Country
    SE
    Correspondent
    Jason Walton

    US Agent

    Business Name
    Keller and Heckman LLP
    Contact Name
    Frederick A. Stearns
    Address
    1001 G Street NW, Suite 500 West
    City
    Washington
    State
    DC
    ZIP
    20001
    Country
    US
    Email
    [email protected]
    Phone
    202 4344288

    Products

    Device Name Product Code
    Tube Tracheostomy And Tube Cuff JOH
    Forceps, General & Plastic Surgery GEN
    Condenser, Heat And Moisture (Artificial Nose) BYD

    Proprietary Names

    SPIRO Speaking Valve SPIRO Tweezer SPIRO Humidifier

    Establishment Types

    Manufacture Medical Device