BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    MouthCAM Pro

    Reg #: 3014980444 · FEI: 3014980444 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    AIOBIO CO., LTD.
    Registration Number
    3014980444
    FEI Number
    3014980444
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    # 306 Sunil Technopia, 555 Dunchon-daero, Jungwon-gu
    City
    Seongnam-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K183121

    Owner / Operator

    Firm Name
    AIOBIO Co., Ltd.
    Operator Number
    10058846
    Address
    #801, 38, Teheran-ro 4-gil, Gangnam-gu
    City
    Seoul
    State
    KR-11
    Postal Code
    06241
    Country
    KR
    Correspondent
    Casey Lee

    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
    Unit, Operative Dental EIA

    Proprietary Names

    MouthCAM Pro Qraypen, Qraypen C

    Establishment Types

    Manufacture Medical Device