BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Coag-Sense Prothrombin Time (PT) / INR Monitoring Device

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

    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
    K183255

    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
    Test, Time, Prothrombin GJS

    Proprietary Names

    Coag-Sense Prothrombin Time (PT) / INR Monitoring Device

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)