i-SENS, Inc.
Founded in 2000 and KOSDAQ-listed in 2013, i-SENS makes blood glucose monitors and point-of-care testing devices.
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Market cap
Business overview
Source: DART corporate disclosureFounded in 2000 and listed on KOSDAQ in 2013, i-SENS is a blood glucose monitor and point-of-care testing (POCT) company. It offers the CareSens self-monitoring blood glucose meter launched in 2003, the CareSens Air continuous glucose monitor launched in September 2023, and electrolyte/blood gas analyzers and cartridges and HbA1c analyzers and cartridges. CareSens features a 0.5 μL sample size and 5-second measurement time, CareSens Air recorded a MARD of 9%, and the company plans to launch a second-generation product, tentatively named CareSens Air2, with improved price competitiveness.
Products & technology
- CareSensBlood glucose measurement
- CareSens AirContinuous glucose monitoring
- CareSens Air2 (tentative)Second-generation continuous glucose monitor
- Electrolyte/blood gas analyzers and cartridgesPOCT electrolyte and blood gas analysis
- HbA1c analyzers and cartridgesHbA1c measurement
- Immunosensors (cardiovascular disease, COVID-19 antibodies, etc.)Immunodiagnostics
Regulatory approvals
data.go.kr · openFDA351 Korean MFDS device approvals · 2002–2026 / 26 US FDA 510(k) · 2008–2023
- MFDSBlood glucose meter for self test2026-07-27Product approval · Class 3체외 제허 26-577 호
- MFDSIVD strip for glucose self test2026-07-27Product approval · Class 3체외 제허 26-576 호
- MFDSContinuous glucose monitoring systems, self-testing, in vivo2026-07-13Product approval · Class 3제허 26-540 호
- MFDSIVD reagents for electrolyte tests2026-07-08Product approval · Class 2체외 제인 26-4625 호
- MFDSIVD reagents for electrolyte tests2026-07-08Product approval · Class 2체외 제인 26-4624 호
- MFDSBlood glucose meter for self test2026-06-22Product approval · Class 3체외 제허 26-471 호
- MFDSIVD strip for glucose self test2026-06-04Product approval · Class 3체외 제허 26-407 호
- MFDSBlood glucose meter for self test2026-05-27Product approval · Class 3체외 제허 26-397 호
- MFDSBlood glucose meter for self test2026-02-04Product approval · Class 3체외 제허 26-105 호
- MFDSBlood glucose meter for self test2026-01-08Product approval · Class 3체외 제허 26-23 호
- MFDSBlood glucose meter for self test2025-12-26Product approval · Class 3체외 제허 25-865 호
- MFDSGlucose analyzer for clinical use2025-12-05Product approval · Class 1체외 제신 25-1609 호
Show 68 more
- MFDSBlood glucose meter for self test2025-12-04Product approval · Class 3체외 제허 25-818 호
- MFDSBlood glucose meter for self test2025-12-04Product approval · Class 3체외 제허 25-817 호
- MFDSBlood glucose meter for self test2025-12-04Product approval · Class 3체외 제허 25-816 호
- MFDSGlucose analyzer for clinical use2025-12-04Product approval · Class 1체외 제신 25-1606 호
- MFDSClinical IVD strip for glucose strip2025-12-02Product approval · Class 2체외 제인 25-5118 호
- MFDSProduct name not recorded2025-11-14Product approval · Class 1신 25-49 호
- MFDSGlucose analyzer for clinical use2025-10-27Product approval · Class 1체외 제신 25-1420 호
- MFDSClinical IVD strip for glucose strip2025-10-21Product approval · Class 2체외 제인 25-4973 호
- MFDSIVD reagents for electrolyte tests2025-09-26Product approval · Class 2체외 제인 25-4908 호
- MFDSBlood glucose meter for self test2025-08-22Product approval · Class 3체외 제허 25-577 호
- MFDSBlood glucose meter for self test2025-08-22Product approval · Class 3체외 제허 25-576 호
- MFDSContinuous glucose monitoring systems, self-testing, in vivo2025-08-22Product approval · Class 3제허 25-575 호
- MFDSClinical IVD strip for glucose strip2025-07-30Product approval · Class 2체외 제인 25-4678 호
- MFDSClinical IVD strip for glucose strip2025-07-30Product approval · Class 2체외 제인 25-4677 호
- MFDSIVD strip for glucose self test2025-07-29Product approval · Class 3체외 제허 25-528 호
- MFDSIVD strip for glucose self test2025-07-29Product approval · Class 3체외 제허 25-527 호
- MFDSIVD strip for glucose self test2025-07-29Product approval · Class 3체외 제허 25-526 호
- MFDSIVD strip for glucose self test2025-07-29Product approval · Class 3체외 제허 25-525 호
- MFDSIVD strip for glucose self test2025-07-29Product approval · Class 3체외 제허 25-521 호
- MFDSBlood collection unit, non-needle2025-07-25Product approval · Class 1제신 25-961 호
- MFDSBlood glucose meter for self test2025-05-19Product approval · Class 3체외 제허 25-326 호
- MFDSIVD strip for glucose self test2025-03-26Product approval · Class 3체외 제허 25-186 호
- MFDSSpectrophotometer for clinical use2025-02-18Product approval · Class 1체외 제신 25-174 호
- MFDSCuff, blood pressure2024-12-26Product approval · Class 1수신 24-2499 호
- MFDSBlood coagulation analyzer for self test2024-12-19Product approval · Class 3체외 제허 24-888 호
- MFDSIVD reagents for diabetes mellitus2024-11-22Product approval · Class 2체외 제인 24-1057 호
- MFDSIVD strip for glucose self test2024-11-05Product approval · Class 3체외 제허 24-768 호
- MFDSBlood glucose meter for self test2024-09-30Product approval · Class 3체외 제허 24-658 호
- MFDSSphygmomanometer, electronic, automatic-inflation, non-portable2024-07-11Product approval · Class 2수인 24-345 호
- MFDSBlood coagulation analyzer for self test2024-07-02Product approval · Class 3체외 제허 24-443 호
- MFDSIVD reagents for cardiac marker2024-01-17Product approval · Class 3체외 제허 24-48 호
- MFDSBlood glucose meter for self test2024-01-02Product approval · Class 3체외 제허 24-4 호
- MFDSIVD strip for glucose self test2024-01-02Product approval · Class 3체외 제허 24-3 호
- MFDSIVD strip for glucose self test2023-12-21Product approval · Class 3체외 제허 23-1170 호
- MFDSBlood glucose meter for self test2023-12-21Product approval · Class 3체외 제허 23-1169 호
- MFDSIVD reagents for cardiac marker2023-11-28Product approval · Class 3체외 제허 23-1092 호
- MFDSBlood collection unit, non-needle2023-11-24Product approval · Class 1제신 23-1685 호
- MFDSBlood glucose meter for self test2023-09-13Product approval · Class 3체외 제허 23-920 호
- MFDSU-healthcare gateway software, class 1Revoked2023-09-06Product approval · Class 1제신 23-1346 호
- MFDSIVD strip for glucose self test2023-08-22Product approval · Class 3체외 제허 23-851 호
- FDAReliOn Premier BLU Blood Glucose Monitoring System2023-08-10
- MFDSContinuous glucose monitoring systems, self-testing, in vivo2023-06-20Product approval · Class 3제허 23-690 호
- MFDSBlood glucose meter for self test2023-02-03Product approval · Class 3체외 제허 23-76 호
- FDALDE4 Lancing Device2022-11-23
- MFDSBlood glucose meter for self test2022-06-10Product approval · Class 3체외 제허 22-378 호
- MFDSIVD strip for glucose self test2022-05-31Product approval · Class 3체외 제허 22-360 호
- MFDSIVD reagents for inflammatory tests2022-04-22Product approval · Class 2체외 제인 22-4320 호
- MFDSClinical IVD strip for glucose strip2022-04-20Product approval · Class 2체외 제인 22-4310 호
- MFDSGlucose analyzer for clinical use2022-04-05Product approval · Class 1체외 제신 22-437 호
- MFDSGlucose analyzer for clinical useRevoked2022-02-23Product approval · Class 1체외 제신 22-254 호
- MFDSBlood glucose meter for self test2022-01-06Product approval · Class 3체외 제허 22-7 호
- MFDSIVD reagents for cardiac marker2021-12-02Product approval · Class 3체외 제허 21-975 호
- MFDSBlood glucose meter for self test2021-11-22Product approval · Class 3체외 제허 21-938 호
- MFDSIVD strip for glucose self test2021-11-02Product approval · Class 3체외 제허 21-875 호
- MFDSBlood glucose meter for self test2021-10-28Product approval · Class 3체외 제허 21-865 호
- MFDSClinical IVD strip for glucose strip2021-10-08Product approval · Class 2체외 제인 21-4853 호
- FDACareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System2021-10-05
- MFDSBlood glucose meter for self test2021-08-18Product approval · Class 3체외 제허 21-699 호
- MFDSIVD reagents for diabetes mellitus2021-07-28Product approval · Class 2체외 제인 21-4641 호
- MFDSSpectrophotometer for clinical use2021-07-26Product approval · Class 1체외 제신 21-1020 호
- MFDSIVD reagents for cardiac marker2021-07-12Product approval · Class 3체외 제허 21-588 호
- MFDSIVD reagents for electrolyte tests2021-04-08Product approval · Class 2체외 제인 21-4282 호
- MFDSIVD reagents for electrolyte tests2021-04-08Product approval · Class 2체외 제인 21-4281 호
- MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), immunological methodRevoked2021-03-17Product approval · Class 3체외 제허 21-198 호
- MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), immunological methodRevoked2021-02-23Product approval · Class 3체외 제허 21-140 호
- MFDSHematology analyzer, glycohemoglobinRevoked2021-01-05Product approval · Class 1체외 제신 21-4 호
- MFDSGlucose analyzer for clinical use2020-12-29Product approval · Class 1체외 제인 20-5161 호
- MFDSGlucose analyzer for clinical use2020-12-22Product approval · Class 1체외 제신 20-1908 호
Showing the 80 most recent of 377 records.
R&D and key agreements
Source: DART corporate disclosure면역센서 진단시약키트 · 심혈관질환, 코로나19 항체 등 · 연구개발 · Sensor R&D center developing immunosensor reagents and optical measurement systems
CGMS(연속혈당측정기) 개발 · 당뇨병 관리 · 양산 · CGMS R&D center developed the continuous glucose monitoring sensor and data management system, commercialized as CareSens Air
Companies approved for the same productsMedical Devices
Ranked by how many MFDS product categories overlap. Not a ranking — a pointer to where to look.
KOSPI-listed in-vitro diagnostics company known for the STANDARD Q antigen/antibody test kits.
Founded 1996, listed on KOSDAQ in 2024, OSANG HEALTHCARE develops and sells biochemistry, immunodiagnostic, and molecular IVD products.
GC Medical Science Corporation, KOSDAQ-listed since 2014, operates diagnostic reagent, blood glucose, and hemodialysis solution businesses.
KOSDAQ-listed point-of-care immunodiagnostics company supplying diagnostic cartridges and the ichroma/AFIAS instrument series.
KOSDAQ-listed IVD company producing time-resolved fluorescence immunodiagnostic products under the Exdia TRF brand.
KOSDAQ-listed in-vitro diagnostics company developing the LabChip-based VERI-Q molecular diagnostic device series.
Founded in 2011 and KOSDAQ-listed in 2019, Sugentech develops multiplex immunoblot, point-of-care, and digital healthcare diagnostics.
KOSDAQ-listed biotech company developing molecular diagnostics with proprietary C-Tag technology and the NeoPlex product line.
KOSDAQ-listed IVD company producing COVID-19 and HIV point-of-care diagnostic reagents alongside rubber products and entertainment businesses.
Founded in 2017 and KOSDAQ-listed in 2025, DongKook Life Science makes contrast agent products and distributes medical devices.
Founded in 1987 and listed on KOSDAQ in 2000, NanoenTek develops Lab-On-a-Chip in-vitro diagnostic devices and life science instruments.
KOSDAQ-listed IVD company using SG Cap™ multiplex diagnostic technology for infectious disease, cancer, and companion animal testing.
Sources and updates
- Company basics
- Korea Exchange · DART
- Business content
- Compiled from disclosure filings
- AI visibility
- Measured 2026-08-13
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