BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    GE Medical Systems, Israel Ltd.

    Reg #: 9615849 · FEI: 3002973981 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    37
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    GE Medical Systems, Israel Ltd.
    Registration Number
    9615849
    FEI Number
    3002973981
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Nativ Ha'or Street no. 1
    City
    Haifa
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K220800

    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, Imaging, Pulsed Doppler, Ultrasonic IYN
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Echo, Ultrasonic IYO

    Proprietary Names

    L4-20t-RS L10-22-RS 9L-RS Venue Go 8C-RS E8C-RS L8-18i-RS 3Sc-RS 6S-RS ML6-15-RS L4-12t-RS M5Sc-RS 12L-RS 6Tc-RS 12S-RS C1-5-RS Venue Fit Venue L12n-RS C2-9-RS Venue Sprint 6Tc C1-6-D 12S-D 6VT-D 9L-D P2D Vivid S70 M5Sc-D Vivid S60 11L-D P6D 9T-RS C3-10-D 6S-D C2-9-D Venue Trident

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility