BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Portable Digital Color Doppler Ultrasound System AME-D07

    Reg #: 3006791146 · FEI: 3006791146 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    AMELIFE LLC
    Registration Number
    3006791146
    FEI Number
    3006791146
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    8 THE GRN, STE 7302
    City
    Dover
    State
    DE
    ZIP
    19901
    Country
    US

    Regulatory Submissions

    510(k) Number
    K131088

    Owner / Operator

    Firm Name
    AMELIFE LLC
    Operator Number
    10022811
    Address
    World Trade Center Delaware 802 NW St, STE 105
    City
    Wilmington
    State
    DE
    Postal Code
    19801
    Country
    US
    Correspondent
    EZEQUIEL CRIVOLOTTI

    Products

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

    Proprietary Names

    Portable Digital Color Doppler Ultrasound System AME-D07

    Establishment Types

    Repack or Relabel Medical Device