BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    GM85

    Reg #: 3024891354 · FEI: 3024891354 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    DRTECH CORPORATION
    Registration Number
    3024891354
    FEI Number
    3024891354
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5F, 53 Sagimakgol-ro 62beon-gil, Jungwon-gu
    City
    Seongnam-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K222353

    Owner / Operator

    Firm Name
    DRTECH CORPORATION
    Operator Number
    9073399
    Address
    Suite No.2, 3 Floor, 29, Dunchon-daero541beon-gil, Jungwon-gu
    City
    Seongnam-si
    State
    Gyeonggi
    Postal Code
    13216
    Country
    KR
    Correspondent
    SEONGHYUN - AHN

    US Agent

    Business Name
    DRTECH NORTH AMERICA INC.
    Contact Name
    Wonjoong Kwon
    Address
    11350 Old Roswell RD Suite 700 Alpharetta GA
    City
    Alpharetta
    State
    GA
    ZIP
    30009
    Country
    US
    Email
    [email protected]
    Phone
    925 9989759

    Products

    Device Name Product Code
    System, X-Ray, Mobile IZL

    Proprietary Names

    GM85 GM85 with Lite AccE GM85 GM85 with Prestige

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)