BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    DRGEM CORPORATION

    Reg #: 3006551157 · FEI: 3006551157 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    55
    Establishment Types
    2
    Classifications
    9

    Registration Details

    Registration Name
    DRGEM CORPORATION
    Registration Number
    3006551157
    FEI Number
    3006551157
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    7F. E-B/D Gwangmyeong Techno-Park, 60 Haan-ro
    City
    Gwangmyeong-si Gyeongbuk
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K201124

    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, X-Ray, Mobile IZL
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
    System, X-Ray, Stationary KPR
    Tube Mount, X-Ray, Diagnostic IYB
    Collimator, Manual, Radiographic IZX
    Holder, Radiographic Cassette, Wall-Mounted IXY
    System, Image Processing, Radiological LLZ
    Table, Radiographic, Non-Tilting, Powered IZZ
    Generator, High-Voltage, X-Ray, Diagnostic IZO

    Proprietary Names

    TOPAZ-32D, TOPAZ-40D PROMO TOPAZ-40D TOPAZ-32D DIAMOND 5A, DIAMOND 6A, DIAMOND 8A TS-FC4 TS-FM6 TS-CSA TS-FC2 TS-FC6 TS-CSE TS-CSP TS-FT4 TS-FT6 RAYMO DXC-RMH DXC-RML 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 JADE-32, JADE-40 DIAMOND-5A, DIAMOND-6A, DIAMOND-8A, 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 WBS WBS-TA WBS-TM RADMAX SGXR-32S, SGXR-40S, SGXR-52S, SGXR-68S, SGXR-82S, SGXR-C32S, SGXR-C40S, SGXR-C52S, SGXR-U32S, SGXR-U40S PBT-4 PBT-6 PBT-1 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

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility