BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    A-FIT

    Reg #: 3013734919 · FEI: 3013734919 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    THE STANDARD CO., LTD.
    Registration Number
    3013734919
    FEI Number
    3013734919
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    120, Gunpocheomdansaneop 2-ro
    City
    Gunpo-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K173676

    Owner / Operator

    Firm Name
    The Standard Co., Ltd.
    Operator Number
    10055479
    Address
    120, Gunpocheomdansaneop 2-ro
    City
    Gunpo-si
    State
    Gyeonggi
    Postal Code
    15880
    Country
    KR
    Correspondent
    Boyeon Cho

    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
    Powered Laser Surgical Instrument GEX
    Massager, Vacuum, Radio Frequency Induced Heat PBX

    Proprietary Names

    A-FIT

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)