BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    AIOBIO CO., LTD.

    Reg #: 3014980444 · FEI: 3014980444 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    12
    Establishment Types
    3
    Classifications
    7

    Registration Details

    Registration Name
    AIOBIO CO., LTD.
    Registration Number
    3014980444
    FEI Number
    3014980444
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    # 306 Sunil Technopia, 555 Dunchon-daero, Jungwon-gu
    City
    Seongnam-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K221275

    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 Ste 610
    City
    Houston
    State
    TX
    ZIP
    77054
    Country
    US
    Email
    [email protected]
    Phone
    713 4672607

    Products

    Device Name Product Code
    Gag, Mouth KBN
    Laser, Fluorescence Caries Detection NBL
    Light, Operating, Dental EAZ
    Unit, Operative Dental EIA
    Unit, Operative Dental, Accessories NRD
    Light, Examination, Medical, Battery Powered KYT
    System, Digital Image Communications, Radiological LMD

    Proprietary Names

    GAG, mouth W block LINKDENS QC Qraycam PRO LINKDENS VU Qrayview pro Qraypen, Qraypen C MouthCAM Pro Outer Hood Qscan Plus battery-powered medical examination light LINK DENS CLINIC LINKDENS VIEWER

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device Complaint File Establishment per 21 CFR 820.198