BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Super Trac

    Reg #: 3007736973 · FEI: 3007736973 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sunwa Ltd.
    Registration Number
    3007736973
    FEI Number
    3007736973
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    571, Negishi
    City
    Sayama Saitama
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K981486

    Owner / Operator

    Firm Name
    Sunwa Ltd. / Misawa
    Operator Number
    10029001
    Address
    5-21-5, Sedagaya, Shibuya-ku
    City
    Tokyo
    State
    Saitama
    Postal Code
    1510051
    Country
    JP
    Correspondent
    Rintaro Misawa

    US Agent

    Business Name
    FDAIMPORTS LLC
    Contact Name
    FDAIMPORTS.COM LLC
    Address
    2631 Housley Road, #1211
    City
    Annapolis
    State
    MD
    ZIP
    21401
    Country
    US
    Email
    [email protected]
    Phone
    410 2202800

    Products

    Device Name Product Code
    Elevator, Wheelchair, Portable ING

    Proprietary Names

    Super Trac

    Establishment Types

    Manufacture Medical Device