BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    DEXCOWIN CO., LTD.

    Reg #: 3007065358 · FEI: 3007065358 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    15
    Establishment Types
    3
    Classifications
    6

    Registration Details

    Registration Name
    DEXCOWIN CO., LTD.
    Registration Number
    3007065358
    FEI Number
    3007065358
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    901-905, 25, Gasan digital 1-ro, Geumcheon-gu
    City
    Seoul
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K173046

    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 Ste 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
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
    System, X-Ray, Mobile IZL
    Tube Mount, X-Ray, Diagnostic IYB
    Bracket, Metal, Orthodontic EJF
    System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations NOF

    Proprietary Names

    Cocoon DX-7017 Cocoon DX-7020 CS 2500P Rex 2 COCOON SOLO (DX-7020s) ADX6000 ADX6000s AllMy T Stand Tiggle iRay D3 DX3000 ADX 4000 iRay D4 RayCam iCam Plus

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Export Device to the United States But Perform No Other Operation on Device