BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    SG HEALTHCARE CO LTD

    Reg #: 3009715136 · FEI: 3009715136 · Expires 2026
    View on FDA
    Products
    14
    Proprietary Names
    27
    Establishment Types
    3
    Classifications
    14

    Registration Details

    Registration Name
    SG HEALTHCARE CO LTD
    Registration Number
    3009715136
    FEI Number
    3009715136
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    10, Yangnyeong-ro
    City
    Moga-myeon, Icheon-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K230241

    Owner / Operator

    Firm Name
    SG Healthcare Co. Ltd
    Operator Number
    10046997
    Address
    10, Yangnyeong-ro
    City
    Moga-myeon, Icheon-si
    State
    Gyeonggi
    Postal Code
    17408
    Country
    KR

    US Agent

    Business Name
    Kamm & Associates
    Contact Name
    Daniel Kamm
    Address
    8870 Ravello Ct
    City
    Naples
    State
    FL
    ZIP
    34114
    Country
    US
    Email
    [email protected]
    Phone
    847 3741727

    Products

    Device Name Product Code
    System, X-Ray, Stationary KPR
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
    System, X-Ray, Angiographic IZI
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Interventional Fluoroscopic X-Ray System OWB
    System, X-Ray, Mobile IZL
    Image-Intensified Fluoroscopic X-Ray System, Mobile OXO
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Transducer, Ultrasonic, Diagnostic ITX
    Table, Radiographic, Non-Tilting, Powered IZZ
    System, Nuclear Magnetic Resonance Imaging LNH
    X-Ray, Tomography, Computed, Dental OAS
    Generator, High-Voltage, X-Ray, Diagnostic IZO

    Proprietary Names

    Jumong General Garion PXP-15/20/40HF GARION T6 JUMONG JUMONG RETRO Jumong Retro 4343A Jumong Mobile Jumong M INVICTUS G5 Hasla Jumong E Jumong C Jumong S Jumong U Jumong F EVA HF 525 Jumong V Invictus 1.5 G10 ZR75PN65 ZR75PN50 ZR75PN80 ZR75PN32 ZR75PN40

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Export Device to the United States But Perform No Other Operation on Device