BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    DK MEDICAL SYSTEMS CO., LTD.

    Reg #: 3014403439 · FEI: 3014403439 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    DK MEDICAL SYSTEMS CO., LTD.
    Registration Number
    3014403439
    FEI Number
    3014403439
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    52, Chupalsandan 1-gil, Paengseong-eup,
    City
    Pyeongtaek-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K250790

    Owner / Operator

    Firm Name
    DK Medical Systems Co., Ltd.
    Operator Number
    10082850
    Address
    52, Chupalsandan 1-gil, Paengseong-eup,
    City
    Pyeongtaek-si
    State
    Gyeonggi
    Postal Code
    17998
    Country
    KR

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    System, X-Ray, Stationary KPR
    Holder, Radiographic Cassette, Wall-Mounted IXY
    System, X-Ray, Mobile IZL
    Table, Radiographic, Non-Tilting, Powered IZZ
    Tube Mount, X-Ray, Diagnostic IYB

    Proprietary Names

    INNOVISION-DXII AeroDR RS AeroDR TX c02 INNOVISION-EXII DS-90A INNOVISION-P5 TE-90A TF-90A SF-90A Elin-T4A

    Establishment Types

    Manufacture Medical Device