BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    ARCADIS ORBIC (AVAILABLE WITH OPTIONS 3D AND 3D NAVIGATION INTERFACE)

    Reg #: 3002466018 · FEI: 3002466018 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Siemens Healthineers AG
    Registration Number
    3002466018
    FEI Number
    3002466018
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    ROENTGENSTRASSE 19-21
    City
    KEMNATH Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K042793

    Owner / Operator

    Firm Name
    Siemens Healthineers AG
    Operator Number
    8010024
    Address
    Karlheinz-Kaske-Str. 5, --
    City
    Erlangen
    State
    DE-NOTA
    Postal Code
    91052
    Country
    DE

    US Agent

    Business Name
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Contact Name
    Robert Phillips
    Address
    40 Liberty Boulevard, Mailcode: 65-1A
    City
    MALVERN
    State
    PA
    ZIP
    19355
    Country
    US
    Email
    [email protected]
    Phone
    302 2359839

    Products

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

    Proprietary Names

    ARCADIS ORBIC (AVAILABLE WITH OPTIONS 3D AND 3D NAVIGATION INTERFACE)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)