BEUDAMED
    FDA Registration Active 🇫🇷 France

    I-MAX Touch

    Reg #: 9615832 · FEI: 3003026827 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    OWANDY RADIOLOGY
    Registration Number
    9615832
    FEI Number
    3003026827
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2 Rue des vieilles vignes, Marne la Vallée
    City
    CROISSY-BEAUBOURG Seine-et-Marne
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K090749

    Owner / Operator

    Firm Name
    OWANDY RADIOLOGY
    Operator Number
    9042115
    Address
    2 rue des vieilles vignes, --
    City
    CROISSY-BEAUBOURG
    State
    Seine-et-Marne
    Postal Code
    77183
    Country
    FR
    Correspondent
    Eric - FAUVARQUE

    Products

    Device Name Product Code
    Unit, X-Ray, Extraoral With Timer EHD
    System, X-Ray, Extraoral Source, Digital MUH

    Proprietary Names

    I-MAX Touch

    Establishment Types

    Repack or Relabel Medical Device