BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    ECOTRON Co., Ltd.

    Reg #: 3011491794 · FEI: 3011491794 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    13
    Establishment Types
    1
    Classifications
    9

    Registration Details

    Registration Name
    ECOTRON Co., Ltd.
    Registration Number
    3011491794
    FEI Number
    3011491794
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    501, 502, 504, 505, 506 Ho, Hanshin IT Tower II, 47,, Digital-ro 9-gil, Geumcheon-Gu
    City
    Seoul
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K151038

    Owner / Operator

    Firm Name
    ECOTRON Co., Ltd.
    Operator Number
    10049861
    Address
    501, 502, 504, 505, 506 Ho, Hanshin IT Tower II, 47, Digital-ro 9-gil, Geumcheon-Gu
    City
    Seoul
    State
    KR-11
    Postal Code
    08511
    Country
    KR
    Correspondent
    Jun Yong Oh

    US Agent

    Business Name
    ECOTRON AMERICA INC.
    Contact Name
    Hali Park
    Address
    12325 Sw 6th Pl
    City
    Newberry
    State
    FL
    ZIP
    32669
    Country
    US
    Email
    [email protected]
    Phone
    352 3633132

    Products

    Device Name Product Code
    Table, Radiologic KXJ
    System, X-Ray, Mobile IZL
    System, X-Ray, Film Marking, Radiographic JAC
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Image-Intensified Fluoroscopic X-Ray System, Mobile OXO
    Interventional Fluoroscopic X-Ray System OWB
    Unit, X-Ray, Extraoral With Timer EHD
    Generator, High-Voltage, X-Ray, Diagnostic IZO
    Tube Mount, X-Ray, Diagnostic IYB

    Proprietary Names

    EXS-TA40 EXS-TA10 EXS-TA20 EPX Series Mobile X-ray System EPX-F1600, EPX-F2400, EPX-F2800, EPX-F3200, EPX-F4000, EPX-F5000 EXS-BK10 Fluoroscopic Mobile X-ray System, Anyview-500R Extraoral source x-ray system DT-703, ProX Go SXG Series High Voltage Generator SXG-32R, SXG-40R, SXG-52R, SXG-68R, SXG-80R EXS-FC10 EXS-FM10 Anyview-500DR Anyview-320DR Anyview-240DR

    Establishment Types

    Manufacture Medical Device