BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    3Sc-RS

    Reg #: 9710090 · FEI: 3003208270 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    13
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    GE ULTRASOUND KOREA, LTD.
    Registration Number
    9710090
    FEI Number
    3003208270
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    9, Sunhwan-ro 214beon-gil, J, ungwon-gu, Gyeonggi-do
    City
    Seongnam-Si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K250543

    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 Echo, Ultrasonic IYO
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Automated Radiological Image Processing Software QIH
    Transducer, Ultrasonic, Diagnostic ITX

    Proprietary Names

    3Sc-RS C1-5-RS IC9-RS RIC5-9A-RS Voluson Performance 16 RAB6-RS RAB2-6-RS Voluson Performance 18 4C-RS IC9B-RS 12L-RS 12S-RS 9L-RS

    Establishment Types

    Manufacture Medical Device