BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    DRGEM Corporation (Gimcheon Factory)

    Reg #: 3029916061 · FEI: 3029916061 · Expires 2026
    View on FDA
    Products
    14
    Proprietary Names
    68
    Establishment Types
    3
    Classifications
    14

    Registration Details

    Registration Name
    DRGEM Corporation (Gimcheon Factory)
    Registration Number
    3029916061
    FEI Number
    3029916061
    Status
    Active
    Expiry Year
    2026
    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
    K260085

    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
    System, Digital Image Communications, Radiological LMD
    Assembly, Tube Housing, X-Ray, Diagnostic ITY
    System, X-Ray, Mobile IZL
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
    System, X-Ray, Stationary KPR
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Transducer, Ultrasonic, Diagnostic ITX
    Collimator, Manual, Radiographic IZX
    Generator, High-Voltage, X-Ray, Diagnostic IZO
    Holder, Radiographic Cassette, Wall-Mounted IXY
    System, Image Processing, Radiological LLZ
    Tube Mount, X-Ray, Diagnostic IYB
    Table, Radiographic, Non-Tilting, Powered IZZ

    Proprietary Names

    GEMPACS DXT-17U DXT-12M DXT-8M DXT-14U DXT-10M DXT-11M DXT-15U DXT-13L DXT-19U DXT-11L RAYMO DIAMOND-5A, DIAMOND-6A, DIAMOND-8A, DS20 DXC-RMH DXC-RML DS30 MXR-35 GXR-68 GXR-82 GXR-C40 GXR-40 GXR-32 GXR-U40 GXR-U32 GXR-52 GXR-C52 GXR-C32 GXR-E32 GXR-E40 GXR-EC40 GXR-EC50 GXR-EC25 GXR-EC32 GXR-E25 GXR-E20 GXR-EC20 TOPAZ-32D, TOPAZ-40D WBS WBS-TA WBS-TM RADMAX DIAMOND 5A, DIAMOND 6A, DIAMOND 8A PROMO GXR-E20S, GXR-E25S, GXR-E32S, GXR-E40S FDR Clinica FGXR-EC20S, FDR Clinica FGXR-EC25S, FDR Clinica FGXR-EC32S, FDR Clinica FGXR-EC40S, FDR Clinica FGXR-EC50S GXR-EC20S, GXR-EC25S, GXR-EC32S, GXR-EC40S, GXR-EC50S FDR Clinica FGXR-E20S, FDR Clinica FGXR-E25S, FDR Clinica FGXR-E32S, FDR Clinica FGXR-E40S GXR-32SD, GXR-40SD, GXR-52SD, GXR-68SD, GXR-82SD, GXR-C32SD, GXR-C40SD, GXR-C52SD, GXR-U32SD, GXR-U40SD FDR clinica FGXR-C32S, FDR clinica FGXR-C40S, FDR clinica FGXR-C52S, FDR clinica FGXR-U32S, FDR clinica FGXR-U40S 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 TOPAZ-40D TOPAZ-32D TS-FC4 TS-FM6 TS-CSA TS-FC2 TS-FC6 TS-CSE TS-CSP TS-FT4 TS-FT6 PBT-4 PBT-6 PBT-1 JADE-32, JADE-40 SGXR-32S, SGXR-40S, SGXR-52S, SGXR-68S, SGXR-82S, SGXR-C32S, SGXR-C40S, SGXR-C52S, SGXR-U32S, SGXR-U40S

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device