BEUDAMED
    FDA Registration Active 🇺🇸 United States

    E-Cube 12

    Reg #: 3009293490 · FEI: 3009293490 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    ALPINION USA
    Registration Number
    3009293490
    FEI Number
    3009293490
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    21222 30th Dr SE Ste C-122
    City
    Bothell
    State
    WA
    ZIP
    98021
    Country
    US

    Regulatory Submissions

    510(k) Number
    K142884

    Owner / Operator

    Firm Name
    Alpinion USA
    Operator Number
    10042979
    Address
    21222 30th Dr. SE, Ste C-122
    City
    Bothell
    State
    WA
    Postal Code
    98021
    Country
    US
    Correspondent
    Kevin Chun

    Products

    Device Name Product Code
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Echo, Ultrasonic IYO

    Proprietary Names

    E-Cube 12

    Establishment Types

    Repack or Relabel Medical Device