BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    GARION

    Reg #: 3009715136 · FEI: 3009715136 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    SG HEALTHCARE CO LTD
    Registration Number
    3009715136
    FEI Number
    3009715136
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    10, Yangnyeong-ro
    City
    Moga-myeon, Icheon-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K091918

    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
    239 4171727

    Products

    Device Name Product Code
    Image-Intensified Fluoroscopic X-Ray System, Mobile OXO
    Interventional Fluoroscopic X-Ray System OWB
    System, X-Ray, Fluoroscopic, Image-Intensified JAA

    Proprietary Names

    GARION

    Establishment Types

    Repack or Relabel Medical Device