BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    GE Innova IGS 530

    Reg #: 3015872432 · FEI: 3015872432 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    ECHO MAGNET SERVICES B.V.
    Registration Number
    3015872432
    FEI Number
    3015872432
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Middendijk5a
    City
    Helmond Noord-Brabant
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K181403

    Owner / Operator

    Firm Name
    ECHO MAGNET SERVICES B.V.
    Operator Number
    10089081
    Address
    Middendijk5a
    City
    Helmond
    State
    Noord-Brabant
    Postal Code
    5705CC
    Country
    NL
    Correspondent
    EROL CANLI

    Products

    Device Name Product Code
    Image-Intensified Fluoroscopic X-Ray System, Mobile OXO
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Interventional Fluoroscopic X-Ray System OWB
    System, X-Ray, Angiographic IZI

    Proprietary Names

    GE Innova IGS 530

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device