BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    KBBIO CO., LTD.

    Reg #: 3017608802 · FEI: 3017608802 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    KBBIO CO., LTD.
    Registration Number
    3017608802
    FEI Number
    3017608802
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    165 Sunhwan-ro, Jungwon-gu
    City
    Seongnam Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    DEN220052

    Owner / Operator

    Firm Name
    KBBIO Co., Ltd.
    Operator Number
    10078362
    Address
    165 Sunhwan-ro, Jungwon-gu
    City
    Seongnam
    State
    Gyeonggi
    Postal Code
    13207
    Country
    KR
    Correspondent
    Seyeoul Park

    US Agent

    Business Name
    YTS Global Inc
    Contact Name
    Won Lee
    Address
    7406 Alban Station Ct., A108
    City
    Springfield
    State
    VA
    ZIP
    22150
    Country
    US
    Email
    [email protected]
    Phone
    703 3408178

    Products

    Device Name Product Code
    Vaginal Hydrogel Packing System QXR
    Generator, Oxygen, Portable CAW
    Respirator, Surgical MSH

    Proprietary Names

    Vaginal Hydrogel Packing System HC Portable Oxygen Concentrator w/ SOP O2 Respirator, Surgical w/ SOP

    Establishment Types

    Manufacture Medical Device