BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    ACIST EUROPE BV

    Reg #: 3012044688 · FEI: 3012044688 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    5

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    Registration Details

    Registration Name
    ACIST EUROPE BV
    Registration Number
    3012044688
    FEI Number
    3012044688
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Argonstraat 3
    City
    Heerlen Limburg
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K974621

    Owner / Operator

    Firm Name
    ACIST Europe BV
    Operator Number
    10084954
    Address
    Argonstraat 3
    City
    Heerlen
    State
    Limburg
    Postal Code
    6422PH
    Country
    NL
    Correspondent
    Emile Schoffelen

    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
    Plethysmograph, Impedance DSB
    Injector, Contrast Medium, Automatic IZQ
    System, X-Ray, Tomography, Computed JAK
    Pump, Infusion Or Syringe, Extra-Luminal FIH
    Injector And Syringe, Angiographic DXT

    Proprietary Names

    EmpowerCTA+ Injector System Empower CTA Injector System EmpowerMR Injector System FastLoad CTA dual Syringe Pack

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Foreign Private Label Distributor