BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    LDE4 Lancing Device

    Reg #: 3007382160 · FEI: 3007382160 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    i-SENS Wonju Factory
    Registration Number
    3007382160
    FEI Number
    3007382160
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    94-1, Donghwagongdan-ro, Munmak-eup
    City
    Wonju-si Gangwon
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K222656

    Owner / Operator

    Firm Name
    i-SENS, Inc.
    Operator Number
    9083763
    Address
    43, Banpo-daero 28-gil, Seocho-gu
    City
    Seoul
    State
    KR-11
    Postal Code
    06646
    Country
    KR
    Correspondent
    Han Wool Kim

    US Agent

    Business Name
    i-SENS USA, Inc.
    Contact Name
    Yoon Ha Cha
    Address
    3545 Lomita Blvd., Unit D
    City
    Torrance
    State
    CA
    ZIP
    90505
    Country
    US
    Email
    [email protected]
    Phone
    607 3771441

    Products

    Device Name Product Code
    Multiple Use Blood Lancet For Single Patient Use Only QRL

    Proprietary Names

    LDE4 Lancing Device

    Establishment Types

    Repack or Relabel Medical Device