BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    RADISEN CO LTD

    Reg #: 3017004860 · FEI: 3017004860 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    6
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    RADISEN CO LTD
    Registration Number
    3017004860
    FEI Number
    3017004860
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    B-602, Hifield Building, 66, Beolmal-ro, Dongan-gu
    City
    Anyang Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K180989

    Owner / Operator

    Firm Name
    Radisen Co Ltd
    Operator Number
    10079944
    Address
    B-602, Hifield Buiding, 66, Beolmal-ro, Dongan-gu
    City
    Anyang
    State
    Gyeonggi
    Postal Code
    14058
    Country
    KR

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

    Proprietary Names

    PEDRA-17F Digital Flat Panel X-ray Detector PEDRA-17FC Digital Flat Panel X-ray Detector PEDRA-17FG Digital Flat Panel X-ray Detector PEDRA-1417MC Digital Flat Panel X-ray Detector PEDRA-1417MG Digital Flat Panel X-ray Detector AXIR-CX

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198