BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    EmpowerCTA+ Injector System

    Reg #: 3004753774 · FEI: 3004753774 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    Bracco Injeneering S.A.
    Registration Number
    3004753774
    FEI Number
    3004753774
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    AVENUE DE SEVELIN 46
    City
    LAUSANNE Vaud
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K071378

    Owner / Operator

    Firm Name
    Bracco Injeneering
    Operator Number
    9066379
    Address
    7905 FULLER ROAD
    City
    Eden Prairie
    State
    MN
    Postal Code
    55344
    Country
    US

    US Agent

    Business Name
    ACIST Medical Systems, Inc.
    Contact Name
    Jonathan Watkins
    Address
    7905 Fuller Road
    City
    Eden Prairie
    State
    MN
    ZIP
    55344
    Country
    US
    Email
    [email protected]
    Phone
    651 8558002

    Products

    Device Name Product Code
    Injector, Contrast Medium, Automatic IZQ
    Plethysmograph, Impedance DSB
    System, X-Ray, Tomography, Computed JAK

    Proprietary Names

    EmpowerCTA+ Injector System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device