BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    IMAXEON PTY LTD

    Reg #: 3003786696 · FEI: 3003786696 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    IMAXEON PTY LTD
    Registration Number
    3003786696
    FEI Number
    3003786696
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Unit 1, 38-46 South Street
    City
    Rydalmere New South Wales
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K241849

    Owner / Operator

    Firm Name
    Imaxeon Pty Ltd
    Operator Number
    10092112
    Address
    1 Bayer Drive
    City
    Indianola
    State
    PA
    Postal Code
    15051
    Country
    US
    Correspondent
    Anhua Hu

    Products

    Device Name Product Code
    Injector And Syringe, Angiographic DXT
    Injector, Contrast Medium, Automatic IZQ

    Proprietary Names

    MEDRAD Centargo Day Set MEDRAD ISI2 Module (ISI2) MEDRAD Centargo Replacement Spike MEDRAD Centargo CT Injection System MEDRAD Centargo Patient Line

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility