BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    LT-300 HD

    Reg #: 3006179052 · FEI: 3006179052 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Bistos co., ltd.
    Registration Number
    3006179052
    FEI Number
    3006179052
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    522, Geumeo-ro, Pogok-eup,, Cheoin-gu,
    City
    Yongin-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K160380

    Owner / Operator

    Firm Name
    Bistos Co., Ltd.
    Operator Number
    10023402
    Address
    7th Fl., A Bldg., Woolim Lions Valley, 5-cha, 302 Galmachi-ro, Jungwon-gu,
    City
    Seongnam
    State
    Gyeonggi
    Postal Code
    13201
    Country
    KR

    US Agent

    Business Name
    Bistos America
    Contact Name
    Daniel Lim
    Address
    22941 Triton Way, Suite 242
    City
    Laguna Hills
    State
    CA
    ZIP
    92653
    Country
    US
    Email
    [email protected]
    Phone
    949 6148745

    Products

    Device Name Product Code
    Colposcope (And Colpomicroscope) HEX

    Proprietary Names

    LT-300 HD

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)