BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    GUARDIAN Inflation Syringe

    Reg #: 3009475067 · FEI: 3009475067 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    BM KOREA CO., LTD.
    Registration Number
    3009475067
    FEI Number
    3009475067
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Rm, 101, Ivalley Gunpo, Gongdan-ro 149
    City
    Gunpo-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K111593

    Owner / Operator

    Firm Name
    BM KOREA CO., LTD.
    Operator Number
    10039124
    Address
    Rm, 101, Ivalley Gunpo, Gongdan-ro 149
    City
    Gunpo-si
    State
    Gyeonggi
    Postal Code
    15845
    Country
    KR
    Correspondent
    Chang Hwa You

    US Agent

    Business Name
    LK Consulting Group USA, Inc.
    Contact Name
    Priscilla Chung
    Address
    18881 Von Karman Ave STE 160
    City
    Irvine
    State
    CA
    ZIP
    92612
    Country
    US
    Email
    [email protected]
    Phone
    714 2025789

    Products

    Device Name Product Code
    Arthroscope HRX
    Cement, Bone, Vertebroplasty NDN

    Proprietary Names

    GUARDIAN Inflation Syringe GUARDIAN Bone Access Needle GUARDIAN Bone Filler Device GUARDIAN Balloon Catheter GUARDIAN Osteo Introducer System GUARDIAN Inflatable Bone Expander System GUARDIAN Drill

    Establishment Types

    Manufacture Medical Device