BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Balex Bone Expander System

    Reg #: 3011489618 · FEI: 3011489618 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    TAEYEON MEDICAL CO., LTD.
    Registration Number
    3011489618
    FEI Number
    3011489618
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    132-1 Donghwagongdan-Ro, Munmak-eup
    City
    Wonju-si Gangwon
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K202027

    Owner / Operator

    Firm Name
    TAEYEON MEDICAL Co., Ltd.
    Operator Number
    10089805
    Address
    132-1 Donghwagongdan-Ro, Munmak-eup
    City
    Wonju-si
    State
    Gangwon
    Postal Code
    26365
    Country
    KR
    Correspondent
    Gil Woon Choi

    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
    Cement, Bone, Vertebroplasty NDN
    Tamp HXG
    Arthroscope HRX

    Proprietary Names

    Balex Bone Expander System

    Establishment Types

    Manufacture Medical Device