BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    DX3000

    Reg #: 3007065358 · FEI: 3007065358 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    DEXCOWIN CO., LTD.
    Registration Number
    3007065358
    FEI Number
    3007065358
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    901-905, 25, Gasan digital 1-ro, Geumcheon-gu
    City
    Seoul
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K133007

    Owner / Operator

    Firm Name
    Dexcowin Co., Ltd.
    Operator Number
    10025963
    Address
    901-905, 25, Gasan digital 1-ro,, Geumcheon-gu
    City
    Seoul
    State
    KR-11
    Postal Code
    08594
    Country
    KR
    Correspondent
    Seung-Bum Ryu

    US Agent

    Business Name
    Mtech Group LLC
    Contact Name
    Dave Kim
    Address
    7505 Fannin St. Suite 610
    City
    Houston
    State
    TX
    ZIP
    77054
    Country
    US
    Email
    [email protected]
    Phone
    713 4672607

    Products

    Device Name Product Code
    System, X-Ray, Extraoral Source, Digital MUH

    Proprietary Names

    DX3000 iRay D3

    Establishment Types

    Manufacture Medical Device