BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    GLUCOCARD Shine Control Solution

    Reg #: 3030186688 · FEI: 3030186688 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    I-SENS Songdo Factory 2
    Registration Number
    3030186688
    FEI Number
    3030186688
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    43-10, Incheon tower-daero 25beon-gil, Yeonsu-gu
    City
    lncheon Incheon
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K083468

    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 (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Glucose Oxidase, Glucose CGA
    System, Test, Blood Glucose, Over The Counter NBW

    Proprietary Names

    GLUCOCARD Shine Control Solution GLUCOCARD Shine XL Blood Glucose Monitoring System CareSens N Blood Glucose Monitoring System

    Establishment Types

    Manufacture Medical Device