BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    CT ExpresTM 3D Contrast Media Delivery System

    Reg #: 8020864 · FEI: 3005737257 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MEDISIZE IRELAND LTD.
    Registration Number
    8020864
    FEI Number
    3005737257
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    HIGH ROAD
    City
    LETTERKENNY Donegal
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K151048

    Owner / Operator

    Firm Name
    Phillips-Medisize, LLC
    Operator Number
    2183833
    Address
    2202 Carmichael Rd
    City
    Hudson
    State
    WI
    Postal Code
    54016
    Country
    US

    US Agent

    Business Name
    Phillps-Medisize, LLC
    Contact Name
    Julie Weghorn
    Address
    408 Red Cedar Street, Suite 6
    City
    Menomonie
    State
    WI
    ZIP
    54751
    Country
    US
    Email
    [email protected]
    Phone
    715 8315443

    Products

    Device Name Product Code
    Injector, Contrast Medium, Automatic IZQ

    Proprietary Names

    CT ExpresTM 3D Contrast Media Delivery System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)