BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Insulin pen needle

    Reg #: 3013160284 · FEI: 3013160284 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sungshim Medicare Co.,Ltd.
    Registration Number
    3013160284
    FEI Number
    3013160284
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    81, Seomi-ro, Seoun-myeon
    City
    Anseong-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K152334

    Owner / Operator

    Firm Name
    Sungshim Medicare Co.,Ltd.
    Operator Number
    10052486
    Address
    81, Seomi-ro, Seoun-myeon
    City
    Anseong-si
    State
    Gyeonggi
    Postal Code
    17608
    Country
    KR
    Correspondent
    Kim Young Kwan

    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
    92620
    Country
    US
    Email
    [email protected]
    Phone
    714 2025789

    Products

    Device Name Product Code
    Needle, Hypodermic, Single Lumen FMI

    Proprietary Names

    Insulin pen needle

    Establishment Types

    Manufacture Medical Device