BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    GE ULTRASOUND KOREA, LTD.

    Reg #: 9710090 · FEI: 3003208270 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    98
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    GE ULTRASOUND KOREA, LTD.
    Registration Number
    9710090
    FEI Number
    3003208270
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    9, Sunhwan-ro 214beon-gil,, Jungwon-gu, Gyeonggi-do
    City
    Seongnam-Si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K200158

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

    Proprietary Names

    L8-18i-D P6D LOGIQ E10 C1-6VN-D C3-10-D RIC5-9-D C1-6-D M5Sc-D 6S-D IC5-9-D 6Tc-RS L2-9VN-D ML6-15-D L2-9-D BE9CS-D RAB6-D P2D C2-9VN-D C2-9-D 3Sc-RS E8C-RS LOGIQ P9 8C-RS ML6-15-RS L8-18i-RS E8CS-RS L10-22-RS 4C-RS L4-12t-RS 12L-RS 6S-RS 9L-RS C1-5-RS RIC5-9A-RS RAB2-6-RS L12n-RS LOGIQ P7 12S-RS L6-12-RS BE9CS-RS Voluson S10 Voluson S8t Voluson S10 Expert Voluson S8 C2-9-RS IC9B-RS IC9-RS Voluson S6 L3-12-D LOGIQ E10s ML4-20-D ML4-20VN-D ML6-15 9L-D 8C 11L-D BE9CS C1-5-D LOGIQ S7 Expert RAB4-8-D L3-12-RS 12S-D L4-20t-D Voluson Performance 18 RAB6-RS Voluson Performance 16 LOGIQ S8 RSP6-16-D LOGIQ Fortis LOGIQ E10s R2 to R3 UPG Voluson S6 BT16 Voluson S series Voluson S8 BT16 Voluson S series BT16 Voluson S10 BT16 M5sc-RS LOGIQ P10 LOGIQ P8 E7C8L-RS LOGIQ P10 R4 to R4.5 UPG LOGIQ P9 R4 to R4.5 UPG LOGIQ P8 R4 to R4.5 UPG LOGIQ Totus Voluson P6 Voluson P8 Voluson SWIFT+ Voluson SWIFT LOGIQ E10s R2R3 to R4 SW Upgrade W LOGIQ Fortis R3 to R4 SW Upgrade W LOGIQ E10s R2R3 to R4 SW Upgrade LOGIQ Fortis R3 to R4 HW Upgrade LOGIQ Fortis R3 to R4 HW Upgrade W LOGIQ E10s R2R3 to R4 HW Upgrade LOGIQ Fortis R3 to R4 SW Upgrade LOGIQ E10s R2R3 to R4 HW Upgrade W Voluson Signature 20 Voluson Signature 18 L6-24-D

    Establishment Types

    Manufacture Medical Device