BEUDAMED
    FDA Registration Active 🇫🇷 France

    Orion System

    Reg #: 3012834372 · FEI: 3012834372 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BizLink Robotic Solutions France
    Registration Number
    3012834372
    FEI Number
    3012834372
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5 avenue Victor Hugo
    City
    Chartres Eure-et-Loir
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K160518

    Owner / Operator

    Firm Name
    BizLink Robotic Solutions France
    Operator Number
    10055323
    Address
    1 avenue Louis Pasteur, Zone industrielle de Gellainville
    City
    Gellainville
    State
    Eure-et-Loir
    Postal Code
    28630
    Country
    FR

    US Agent

    Business Name
    BizLink Robotic Solutions USA
    Contact Name
    Gregory LARSON
    Address
    100 Kay Industrial Drive
    City
    Lake Orion
    State
    MI
    ZIP
    48359
    Country
    US
    Email
    [email protected]
    Phone
    248 4845549

    Products

    Device Name Product Code
    Couch, Radiation Therapy, Powered JAI

    Proprietary Names

    Orion System

    Establishment Types

    Manufacture Medical Device