BEUDAMED
    FDA Registration Active 🇫🇷 France

    Fibroscan

    Reg #: 3010258456 · FEI: 3010258456 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ECHOSENS
    Registration Number
    3010258456
    FEI Number
    3010258456
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6 rue Ferrus
    City
    Paris
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K150949

    Owner / Operator

    Firm Name
    Echosens
    Operator Number
    10043955
    Address
    6 rue Ferrus
    City
    Paris
    State
    FR-75
    Postal Code
    75014
    Country
    FR

    US Agent

    Business Name
    Echosens North America
    Contact Name
    Jon S. Gingrich
    Address
    1 Research Dr Ste 400b
    City
    Westborough
    State
    MA
    ZIP
    01581
    Country
    US
    Email
    [email protected]
    Phone
    508 6546565

    Products

    Device Name Product Code
    System, Imaging, Pulsed Echo, Ultrasonic IYO

    Proprietary Names

    Fibroscan

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device