BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Allura FD 20 Xper

    Reg #: 3012127758 · FEI: 3012127758 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Siemens Healthcare Limited
    Registration Number
    3012127758
    FEI Number
    3012127758
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1577 North Service Road East
    City
    Oakville Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K033737

    Owner / Operator

    Firm Name
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Operator Number
    9002915
    Address
    40 Liberty Boulevard
    City
    Malvern
    State
    PA
    Postal Code
    19355
    Country
    US

    US Agent

    Business Name
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Contact Name
    Robert Phillips
    Address
    40 Liberty Boulevard
    City
    Malvern
    State
    PA
    ZIP
    19355
    Country
    US
    Email
    [email protected]
    Phone
    302 6319702

    Products

    Device Name Product Code
    Interventional Fluoroscopic X-Ray System OWB
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    System, X-Ray, Angiographic IZI

    Proprietary Names

    Allura FD 20 Xper

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device