BEUDAMED
    FDA Registration Active 🇫🇷 France

    Hepatoscope

    Reg #: 3026405201 · FEI: 3026405201 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    4
    Classifications
    3

    Registration Details

    Registration Name
    E-SCOPICS
    Registration Number
    3026405201
    FEI Number
    3026405201
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    235 rue Leon Foucault, Parc de la Duranne
    City
    Aix-en-Provence Bouches-du-Rhone
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K213102

    Owner / Operator

    Firm Name
    E-Scopics
    Operator Number
    10087219
    Address
    235 rue Leon Foucault, Parc de la Duranne
    City
    Aix-en-Provence
    State
    Bouches-du-Rhone
    Postal Code
    13100
    Country
    FR
    Correspondent
    Claude Cohen-Bacrie

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

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

    Proprietary Names

    Hepatoscope

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device