BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    I-SENS Songdo Factory 2

    Reg #: 3030186688 · FEI: 3030186688 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    38
    Establishment Types
    3
    Classifications
    8

    Registration Details

    Registration Name
    I-SENS Songdo Factory 2
    Registration Number
    3030186688
    FEI Number
    3030186688
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    43-10, Incheon tower-daero 25beon-gil, Yeonsu-gu
    City
    lncheon Incheon
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K170614

    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
    System, Test, Blood Glucose, Over The Counter NBW
    Nitroprusside, Ketones (Urinary, Non-Quant.) JIN
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Glucose Oxidase, Glucose CGA
    Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature FMK
    Test, Time, Prothrombin GJS
    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

    ReliOn Premier BLU Blood Glucose Monitoring System CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System CareSens S Clear BT Blood Glucose Monitoring System Tempo Blood Glucose Monitoring System KetoSens Blood ?-Ketone Monitoring System KetoSens Multi Blood ?-Ketone Monitoring System GLUCOCARD Shine Control Solution GLUCOCARD Shine XL Blood Glucose Monitoring System CareSens N Blood Glucose Monitoring System CareSens Safety Lancet CareSens N Feliz BT Blood Glucose Monitoring System CareSens N Feliz Blood Glucose Monitoring System Coag-Sense Prothrombin Time (PT) / INR Monitoring Device CareSens S Fit BT Blood Glucose Monitoring System CareSens N Voice Blood Glucose Monitoring System ReliOn Premier Voice Blood Glucose Monitoring System CareSens N Mini Blood Glucose Monitoring System ReliOn Premier COMPACT Blood Glucose Monitoring System CareSoft Lancing Device Tempo Lancing Device CareSens N POP Blood Glucose Monitoring System GLUCOCARD Shine Blood Glucose Monitoting System Fifty 50 Blood Glucose Monitoring System 2 Sport Greater Goods Essential Blood Glucose Monitoring System KetoSens BT Blood ?-Ketone Monitoring System CareSens N Voice Multi Blood Glucose Monitoring System Assure Prism multi Blood Glucose Monitoring System Lancet Greater goods lancet Tempo Lancet CareSens Lancet CareSens S Fit Blood Glucose Monitoring System GLUCOCARD Shine Express Blood Glucose Monitoring System GLUCOCARD Shine Connex Blood Glucose Monitoring System CareSens N Voice Square Blood Glucose Monitoring System NoCoding1 Plus Blood Glucose Monitoring System CareSens N Plus BT Blood Glucose Monitoring System tenovi Blood Glucose Monitoring System

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)