BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    FDR clinica FGXR-32S, FDR clinica FGXR-40S, FDR clinica FGXR-52S, FDR clinica FGXR-68S, FDR clinica FGXR-82S

    Reg #: 3029916061 · FEI: 3029916061 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    DRGEM Corporation (Gimcheon Factory)
    Registration Number
    3029916061
    FEI Number
    3029916061
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    213, Saneopdanji-ro, Eomo-myeon, Gimcheon-si, Gyeongsangbuk-do, Republic of Korea
    City
    Gimcheon-si Gyeongbuk
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K242019

    Owner / Operator

    Firm Name
    DRGEM CORPORATION
    Operator Number
    9101499
    Address
    7Fl, E-B/D Gwangmyeong Techno-Park, 60 Haan-ro,
    City
    Gwangmyeong-si
    State
    Gyeonggi
    Postal Code
    14322
    Country
    KR

    US Agent

    Business Name
    DRGEM AMERICA INC
    Contact Name
    Alex Lee
    Address
    13755 HUTTON DR, Suite 500
    City
    Farmers Branch
    State
    TX
    ZIP
    75234
    Country
    US
    Email
    [email protected]
    Phone
    469 6109068

    Products

    Device Name Product Code
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
    System, X-Ray, Stationary KPR

    Proprietary Names

    FDR clinica FGXR-32S, FDR clinica FGXR-40S, FDR clinica FGXR-52S, FDR clinica FGXR-68S, FDR clinica FGXR-82S GXR-32S, GXR-40S, GXR-52S, GXR-68S, GXR-82S, GXR-C32S, GXR-C40S, GXR-C52S, GXR-U32S, GXR-U40S FDR clinica FGXR-C32S, FDR clinica FGXR-C40S, FDR clinica FGXR-C52S, FDR clinica FGXR-U32S, FDR clinica FGXR-U40S GXR-32SD, GXR-40SD, GXR-52SD, GXR-68SD, GXR-82SD, GXR-C32SD, GXR-C40SD, GXR-C52SD, GXR-U32SD, GXR-U40SD

    Establishment Types

    Manufacture Medical Device