BEUDAMED
    FDA Registration Active 🇫🇷 France

    KOELIS

    Reg #: 3008487708 · FEI: 3008487708 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    KOELIS
    Registration Number
    3008487708
    FEI Number
    3008487708
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Building D, 22 Chemin Du Vieux Chene
    City
    MEYLAN Isere
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K141334

    Owner / Operator

    Firm Name
    KOELIS
    Operator Number
    10033933
    Address
    22 Chemin du vieux chene
    City
    MEYLAN
    State
    Isere
    Postal Code
    38240
    Country
    FR
    Correspondent
    Antoine LEROY

    US Agent

    Business Name
    Axelia Partners LLC
    Contact Name
    ALEXANDRA SUHAS
    Address
    185 Alewife Brook Pkwy Ste 210
    City
    Cambridge
    State
    MA
    ZIP
    02138
    Country
    US
    Email
    [email protected]
    Phone
    617 8525333

    Products

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

    Proprietary Names

    REUSABLE GUIDE TRINITY/3D PROSTATE SUITE Disposable Guide Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range

    Establishment Types

    Manufacture Medical Device