BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    BEXCORE Vacuum Assisted Breast Biopsy System; BXC135, BXC140, BXC145 Biopsy Needles

    Reg #: 3012936513 · FEI: 3012936513 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    MEDICALPARK CO. LTD
    Registration Number
    3012936513
    FEI Number
    3012936513
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    7, Saneop-ro 156beon-gil, Gwonseon-gu,
    City
    Suwon-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K171890

    Owner / Operator

    Firm Name
    MEDICALPARK CO. LTD
    Operator Number
    10059444
    Address
    #624, A-dong, Bundang Suji U-Tower, 767, Sinsu-ro, Suji-gu
    City
    Yongin-si
    State
    Gyeonggi
    Postal Code
    16827
    Country
    KR
    Correspondent
    Hye-Yeon Park

    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
    Biopsy Needle FCG
    Instrument, Biopsy KNW

    Proprietary Names

    BEXCORE Vacuum Assisted Breast Biopsy System; BXC135, BXC140, BXC145 Biopsy Needles

    Establishment Types

    Manufacture Medical Device