BEUDAMED
    FDA Registration Active 🇫🇷 France

    ECHOSENS

    Reg #: 3010258456 · FEI: 3010258456 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    18
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    ECHOSENS
    Registration Number
    3010258456
    FEI Number
    3010258456
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    6 rue Ferrus
    City
    Paris
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K181547

    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
    Transducer, Ultrasonic, Diagnostic ITX
    Calculator/Data Processing Module, For Clinical Use JQP
    Medical Device Data System OUG

    Proprietary Names

    FibroScan® S+ probe Fibroscan 530 Compact Fibroscan FibroScan 430 Mini+ FibroScan 230 FibroScan 630 Agile 3+ Calculator Fast Calculator Agile 4 Calculator FibroScan S+ probe FibroScan FibroScan 502 Touch M+ probe XL+ probe Fibroview Report Fibroview Data Solution myFibroScan FibroScan Gateway

    Establishment Types

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