BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Acuity DRe 1417w

    Reg #: 3020775384 · FEI: 3020775384 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    DE TECH CO.,LTD
    Registration Number
    3020775384
    FEI Number
    3020775384
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2F, 110, Gyeongancheon-ro, Gwangju-si, Gyeonggi-do, Republic of Korea
    City
    Gwangju-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K210919

    Owner / Operator

    Firm Name
    DE Tech Co.,Ltd
    Operator Number
    10082685
    Address
    2F, 110, Gyeongancheon-ro, Gwangju-si, Gyeonggi-do, Republic of Korea
    City
    Gwangju-si
    State
    Gyeonggi
    Postal Code
    12740
    Country
    KR
    Correspondent
    Heeyoung Jeong

    US Agent

    Business Name
    Radmedix
    Contact Name
    Gabriel Issa
    Address
    2510 Lance Dr
    City
    Dayton
    State
    OH
    ZIP
    45409
    Country
    US
    Email
    [email protected]
    Phone
    844 7236334 ext. 55

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB

    Proprietary Names

    Acuity DRe 1417w Acuity DRe 1717w

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)