BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    SC1 Handheld Ultrasound Imaging System (Model: SC1)

    Reg #: 3008515880 · FEI: 3008515880 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    EZONO AG
    Registration Number
    3008515880
    FEI Number
    3008515880
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Spitzweidenweg 32
    City
    Jena Thuringia
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K210468

    Owner / Operator

    Firm Name
    eZono AG
    Operator Number
    10039166
    Address
    Spitzweidenweg 32
    City
    Jena
    State
    Thuringia
    Postal Code
    07743
    Country
    DE

    Products

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

    Proprietary Names

    SC1 Handheld Ultrasound Imaging System (Model: SC1)

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device