BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    CareSens Lancet

    Reg #: 3007382160 · FEI: 3007382160 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    2

    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
    K220475

    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
    Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature QRK
    Multiple Use Blood Lancet For Single Patient Use Only QRL

    Proprietary Names

    CareSens Lancet Greater goods lancet Tempo Lancet Lancet

    Establishment Types

    Repack or Relabel Medical Device