BEUDAMED
    FDA Registration Active 🇫🇷 France

    A01021 - Broach Set SPX1

    Reg #: 3021060474 · FEI: 3021060474 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    ECENTIAL ROBOTICS
    Registration Number
    3021060474
    FEI Number
    3021060474
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2 avenue de Vignate, Zone de Mayencin II Parc Equation Batiment 1
    City
    Gieres Isere
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K220627

    Owner / Operator

    Firm Name
    Ecential Robotics
    Operator Number
    10084446
    Address
    2 avenue de Vignate, Zone de Mayencin II Parc Equation Batiment 1
    City
    Gieres
    State
    Isere
    Postal Code
    38610
    Country
    FR
    Correspondent
    Elodie bouillet

    Products

    Device Name Product Code
    Image-Intensified Fluoroscopic X-Ray System, Mobile OXO
    Interventional Fluoroscopic X-Ray System OWB
    System, X-Ray, Fluoroscopic, Image-Intensified JAA

    Proprietary Names

    A01021 - Broach Set SPX1 A01018 - 3D Imaging Set SPX1

    Establishment Types

    Manufacture Medical Device