BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    BSD3543 Digital Flat Panel X-ray Detector

    Reg #: 3013599033 · FEI: 3013599033 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    BONTECH CO., LTD
    Registration Number
    3013599033
    FEI Number
    3013599033
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Digital Empire D #1201,16, Deogyeong-daero,1556 beon-gil, Youngtong-gu Youngtong-dong 980-3
    City
    Suwon-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K162487

    Owner / Operator

    Firm Name
    Bontech Co., Ltd
    Operator Number
    10062226
    Address
    Digital Empire D #1201,16, Deogyeong-daero,1556 beon-gil, Youngtong-gu Youngtong-dong 980-3
    City
    Suwon-si
    State
    Gyeonggi
    Postal Code
    443702
    Country
    KR
    Correspondent
    Dave Kim

    US Agent

    Business Name
    Mtech Group LLC
    Contact Name
    Dave Kim
    Address
    7505 Fannin St. Suite 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

    Proprietary Names

    BSD3543 Digital Flat Panel X-ray Detector BSD3543 BT-DA22-IA(CsI) BT-DB22-IA(Gdos)

    Establishment Types

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