BEUDAMED
    FDA Registration Active 🇫🇷 France

    IMACTIS, SAS

    Reg #: 3015060224 · FEI: 3015060224 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    IMACTIS, SAS
    Registration Number
    3015060224
    FEI Number
    3015060224
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    20 rue du Tour de l'eau
    City
    SAINT MARTIN D'HERES
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K162314

    Owner / Operator

    Firm Name
    GE HealthCare Technologies Inc.
    Operator Number
    9912004
    Address
    3000 N. Grandview Blvd
    City
    Waukesha
    State
    WI
    Postal Code
    53188
    Country
    US

    US Agent

    Business Name
    GE HealthCare Technologies, Inc
    Contact Name
    Tracey Holevas
    Address
    3000 N. Grandview BLVD
    City
    Waukesha
    State
    WI
    ZIP
    53188
    Country
    US
    Email
    [email protected]
    Phone
    262 3092157

    Products

    Device Name Product Code
    System, X-Ray, Tomography, Computed JAK
    Cart, Emergency, Cardiopulmonary (Excluding Equipment) BZN

    Proprietary Names

    USMAN MAGNETIC NAVIGATION STATION IMACTIS CT-Navigation system Imactis Mobile Cart

    Establishment Types

    Manufacture Medical Device