BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Portex Spinal Needles

    Reg #: 3004504731 · FEI: 3004504731 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Tae-Chang Industrial Co., Ltd.
    Registration Number
    3004504731
    FEI Number
    3004504731
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    8-18, Bojeokdong-gil, Useong-myeon
    City
    Gongju-si Chungnam
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K983858

    Owner / Operator

    Firm Name
    Tae-Chang Industrial Co., Ltd.
    Operator Number
    9062236
    Address
    8-18, Bojeokdong-gil, Useong-myeon
    City
    Gongju-si
    State
    Chungnam
    Postal Code
    32533
    Country
    KR
    Correspondent
    Jung-ryun In

    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
    Needle, Spinal, Short Term MIA

    Proprietary Names

    Portex Spinal Needles

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)