BEUDAMED
    FDA Registration Active 🇿🇦 South Africa

    GE BRIGHTSPEED ELITE SELECT CT

    Reg #: 3025398421 · FEI: 3025398421 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Y2000 MEDICAL ELECTRONICS CC
    Registration Number
    3025398421
    FEI Number
    3025398421
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1017 Martha Street, Eldoraigne, Ext 1
    City
    Centurion Gauteng
    Country
    ZA

    Regulatory Submissions

    510(k) Number
    K082816

    Owner / Operator

    Firm Name
    Y2000 Medical Electronics cc
    Operator Number
    10091215
    Address
    1017 Martha Street, Eldoraigne, Ext 1
    City
    Centurion
    State
    Gauteng
    Postal Code
    0157
    Country
    ZA
    Correspondent
    Abraham A Wessels

    US Agent

    Business Name
    Block Imaging Parts & Service
    Contact Name
    Grace Lyon
    Address
    1845 Cedar St
    City
    Holt
    State
    MI
    ZIP
    48842
    Country
    US
    Email
    [email protected]
    Phone
    517 6688800

    Products

    Device Name Product Code
    System, X-Ray, Tomography, Computed JAK

    Proprietary Names

    GE BRIGHTSPEED ELITE SELECT CT GE BRIGHTSPEED EDGE SELECT CT GE BRIGHTSPEED EXCEL SELECT GE BRIGHTSPEED ELITE CT

    Establishment Types

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