BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    BM KOREA CO., LTD.

    Reg #: 3009475067 · FEI: 3009475067 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    16
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    BM KOREA CO., LTD.
    Registration Number
    3009475067
    FEI Number
    3009475067
    Status
    Active
    Expiry Year
    2026
    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
    2552 Walnut Ave Ste 230
    City
    Tustin
    State
    CA
    ZIP
    92780
    Country
    US
    Email
    [email protected]
    Phone
    714 9225276

    Products

    Device Name Product Code
    Arthroscope HRX
    Cement, Bone, Vertebroplasty NDN
    Device, Percutaneous, Biopsy MJG
    Mixer, Cement, For Clinical Use JDZ

    Proprietary Names

    GUARDIAN Bone Filler Device GUARDIAN Osteo Introducer System GUARDIAN Inflation Syringe GUARDIAN Balloon Catheter GUARDIAN Bone Access Needle GUARDIAN Inflatable Bone Expander System GUARDIAN Drill GUARDIAN-SG BONE BIOPSY GUARDIAN-MD GUARDIAN-SG Inflation Syringe GUARDIAN-SG Bone Filler Device GUARDIAN-SG Osteo Introducer System GUARDIAN-SG Needle Cement Dispenser System GUARDIAN-SG Balloon Catheter GUARDIAN-SG Drill GUARDIAN-SG Inflatable Bone Expander System

    Establishment Types

    Manufacture Medical Device