BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    EXSYS DEXi (EXSYS DEXi-A402S-FRM)

    Reg #: 3005172103 · FEI: 3005172103 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    15
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    DRTECH Corporation
    Registration Number
    3005172103
    FEI Number
    3005172103
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Suite No.1, 2 Floor / Suite No.2, 3 Floor, 29, Dunchon-daero 541beon-gil, JUNGWON-GU
    City
    Seongnam-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K242847

    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

    Products

    Device Name Product Code
    System, X-Ray, Stationary KPR

    Proprietary Names

    EXSYS DEXi (EXSYS DEXi-A402S-FRM) EXSYS DEXi (EXSYS DEXi-D402S-FRM) EXSYS DEXi (EXSYS DEXi-D402S-FRA) EXSYS DEXi (EXSYS DEXi-A503T-FRM) EXSYS DEXi (EXSYS DEXi-D401S-FRA) EXSYS DEXi (EXSYS DEXi-D402P-FRA) EXSYS DEXi (EXSYS DEXi-D402P-FRM) EXSYS DEXi (EXSYS DEXi-A401P-FRM) EXSYS DEXi (EXSYS DEXi-A401S-FRM) EXSYS DEXi (EXSYS DEXi-D401S-FRM) EXSYS DEXi (EXSYS DEXi-D503T-FRM) EXSYS DEXi (EXSYS DEXi-D401P-FRM) EXSYS DEXi (EXSYS DEXi-A402P-FRM) EXSYS DEXi (EXSYS DEXi-D401P-FRA) EXSYS DEXi (EXSYS DEXi-D503T-FRA)

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility