BEUDAMED
    FDA Registration Active 🇫🇷 France

    FETOLY-HEART

    Reg #: 3033557977 · FEI: 3033557977 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    DIAGNOLY
    Registration Number
    3033557977
    FEI Number
    3033557977
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Batiment Terra Mundi, 2 Place De Francfort
    City
    Lyon 3e Arrondissement Rhone
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K241380

    Owner / Operator

    Firm Name
    DIAGNOLY
    Operator Number
    10091679
    Address
    2 place de Francfort, Bat.Terra Mundi
    City
    LYON
    State
    Rhone
    Postal Code
    69003
    Country
    FR

    Products

    Device Name Product Code
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Automated Radiological Image Processing Software QIH

    Proprietary Names

    FETOLY-HEART

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device