I-SENS, The Republic of Korea - Komachine Supplier Profile and Product List

- I-SENS is a global healthcare company specializing in medical devices, developing, manufacturing, and selling various in vitro diagnostic medical devices such as self-blood glucose meters, continuous glucose monitoring systems, blood gas, and electrolyte analyzers. The company provides innovative diagnostic solutions based on biosensor technology, contributing to human health. It exports products to approximately 110 countries worldwide, strengthening its position in the global market. I-SENS is expanding its business into point-of-care testing (POCT) and animal diagnostic systems. The company pursues growth through continuous research and development and quality management.I-SENS is a global healthcare company specializing in medical devices, developing, manufacturing, and selling various in vitro diagnostic medical devices such as self-blood glucose meters, continuous glucose monitoring systems, blood gas, and electrolyte analyzers. The company provides innovative diagnostic solutions based on biosensor technology, contributing to human health. It exports products to approximately 110 countries worldwide, strengthening its position in the global market. I-SENS is expanding its business into point-of-care testing (POCT) and animal diagnostic systems. The company pursues growth through continuous research and development and quality management.
- Blood Glucose Monitoring System (BGMS): CareSens N Premier is an electrochemical blood glucose meter, offering a 5-second measurement time and a small 0.5 μL blood sample volume, capable of storing 1,000 results. It features Bluetooth connectivity for SmartLog app integration and a lifetime warranty. CareSens Dual measures both blood glucose and beta-ketone levels, utilizing GDH-FAD-based test strips with Bluetooth wireless transmission capabilities. Glucose measurement requires 0.4 μL of blood and takes 5 seconds, while ketone measurement requires 0.5 μL of blood and takes 8 seconds.Blood Glucose Monitoring System (BGMS): CareSens N Premier is an electrochemical blood glucose meter, offering a 5-second measurement time and a small 0.5 μL blood sample volume, capable of storing 1,000 results. It features Bluetooth connectivity for SmartLog app integration and a lifetime warranty. CareSens Dual measures both blood glucose and beta-ketone levels, utilizing GDH-FAD-based test strips with Bluetooth wireless transmission capabilities. Glucose measurement requires 0.4 μL of blood and takes 5 seconds, while ketone measurement requires 0.5 μL of blood and takes 8 seconds.
- Continuous Glucose Monitoring System (CGMS): CareSens Air is Korea's first domestically developed continuous glucose monitoring system, providing real-time blood glucose data and trend analysis, and has obtained CE certification. It offers a 15-day usage period and blood glucose calibration function for enhanced user convenience. The next-generation product, CareSens Air2, is under development, aiming for a smaller sensor, an 18-day usage period, and a 20-minute stabilization time.Continuous Glucose Monitoring System (CGMS): CareSens Air is Korea's first domestically developed continuous glucose monitoring system, providing real-time blood glucose data and trend analysis, and has obtained CE certification. It offers a 15-day usage period and blood glucose calibration function for enhanced user convenience. The next-generation product, CareSens Air2, is under development, aiming for a smaller sensor, an 18-day usage period, and a 20-minute stabilization time.
- Point-of-Care Testing (POCT) System: The i-Smart 300 blood gas analyzer features an all-in-one cartridge system including electrodes, reagents, and all consumables, enabling rapid 50-second measurements with a small 100 μL blood sample for on-site testing. The i-Smart 30 electrolyte analyzer applies proprietary electrochemical sensor technology to analyze Na, K, Cl, and Hct from a 50 μL sample in 35 seconds, also featuring an all-in-one cartridge system, touchscreen, and voice guidance.Point-of-Care Testing (POCT) System: The i-Smart 300 blood gas analyzer features an all-in-one cartridge system including electrodes, reagents, and all consumables, enabling rapid 50-second measurements with a small 100 μL blood sample for on-site testing. The i-Smart 30 electrolyte analyzer applies proprietary electrochemical sensor technology to analyze Na, K, Cl, and Hct from a 50 μL sample in 35 seconds, also featuring an all-in-one cartridge system, touchscreen, and voice guidance.
- Veterinary Diagnostic System: Under the VetMate® brand, the company offers the i-Smart 300 VET animal blood gas and electrolyte analyzer and the CareSign-V animal immunochemistry analyzer. Pointcare V3 is a veterinary clinical chemistry analyzer capable of blood gas measurement and can measure up to 24 items at once, featuring a compact size and built-in battery.Veterinary Diagnostic System: Under the VetMate® brand, the company offers the i-Smart 300 VET animal blood gas and electrolyte analyzer and the CareSign-V animal immunochemistry analyzer. Pointcare V3 is a veterinary clinical chemistry analyzer capable of blood gas measurement and can measure up to 24 items at once, featuring a compact size and built-in battery.
- Proprietary Biosensor Technology: Possession of advanced biosensor technology enabling self-blood glucose meters with ultra-small 0.5 μL blood sampling and rapid 5-second measurement speeds. This superior performance provides a competitive edge in the market. Precision diagnostic capabilities are based on electrochemical and biosensor technologies.Proprietary Biosensor Technology: Possession of advanced biosensor technology enabling self-blood glucose meters with ultra-small 0.5 μL blood sampling and rapid 5-second measurement speeds. This superior performance provides a competitive edge in the market. Precision diagnostic capabilities are based on electrochemical and biosensor technologies.
- Extensive Product Portfolio and Localization Leadership: Establishment of a diverse diagnostic system including self-blood glucose meters, continuous glucose monitoring systems, blood gas and electrolyte analyzers, glycated hemoglobin analyzers, and immunochemistry analyzers. Notably, the company developed and commercialized 'CareSens Air,' the first continuous glucose monitoring system in Korea, reducing import dependence and leading the market.Extensive Product Portfolio and Localization Leadership: Establishment of a diverse diagnostic system including self-blood glucose meters, continuous glucose monitoring systems, blood gas and electrolyte analyzers, glycated hemoglobin analyzers, and immunochemistry analyzers. Notably, the company developed and commercialized 'CareSens Air,' the first continuous glucose monitoring system in Korea, reducing import dependence and leading the market.
- Global Market Expansion and Localization Strategy: Exporting products to over 110 countries worldwide, receiving strong positive responses in developed markets such as Korea, the US, and Europe. Active pursuit of global localization strategies, including establishing sales subsidiaries in China, Mexico, India, Chile, Malaysia, and Germany. Expansion into the European market through key distribution partnerships, such as with 77 Elektronika Ltd. in Hungary.Global Market Expansion and Localization Strategy: Exporting products to over 110 countries worldwide, receiving strong positive responses in developed markets such as Korea, the US, and Europe. Active pursuit of global localization strategies, including establishing sales subsidiaries in China, Mexico, India, Chile, Malaysia, and Germany. Expansion into the European market through key distribution partnerships, such as with 77 Elektronika Ltd. in Hungary.
- User-Centric Convenience and Data Utilization: Development of products with enhanced user convenience features such as smartphone app integration, Bluetooth wireless transmission, voice guidance, and touchscreens. Utilization of Bluetooth, NFC, and LTE communication functions to collect diabetes patient data, contributing to the development of AI-based personalized chronic disease management services through participation in the Lifelog Big Data Platform establishment project.User-Centric Convenience and Data Utilization: Development of products with enhanced user convenience features such as smartphone app integration, Bluetooth wireless transmission, voice guidance, and touchscreens. Utilization of Bluetooth, NFC, and LTE communication functions to collect diabetes patient data, contributing to the development of AI-based personalized chronic disease management services through participation in the Lifelog Big Data Platform establishment project.
- Stable Production Capacity and Quality Management: Holding an annual production capacity of over 1.6 billion strips as of 2018. Completion of the Songdo 2nd factory and expansion of the CGM automated production line, quadrupling annual production capacity to 2 million units. Operation of a stringent quality management system, including compliance with ISO 15197:2013 accuracy standards and CE certification.Stable Production Capacity and Quality Management: Holding an annual production capacity of over 1.6 billion strips as of 2018. Completion of the Songdo 2nd factory and expansion of the CGM automated production line, quadrupling annual production capacity to 2 million units. Operation of a stringent quality management system, including compliance with ISO 15197:2013 accuracy standards and CE certification.
- High Brand Recognition and Trust: The 'CareSens' brand has received the 'Korea First Brand Award' in the blood glucose meter category for 15 consecutive years (as of 2026) and the 'Brand of the Year Award' for 13 consecutive years (as of 2025), establishing unrivaled brand trust in the domestic market.High Brand Recognition and Trust: The 'CareSens' brand has received the 'Korea First Brand Award' in the blood glucose meter category for 15 consecutive years (as of 2026) and the 'Brand of the Year Award' for 13 consecutive years (as of 2025), establishing unrivaled brand trust in the domestic market.
- Medical Device IndustryMedical Device Industry
- Healthcare IndustryHealthcare Industry
- In Vitro Diagnostics (IVD) IndustryIn Vitro Diagnostics (IVD) Industry
- Animal Diagnostics IndustryAnimal Diagnostics Industry
- Chronic Disease Management IndustryChronic Disease Management Industry
- Digital Healthcare IndustryDigital Healthcare Industry
- South Korea, China, Japan, India, MalaysiaSouth Korea, China, Japan, India, Malaysia
- Across Europe (part of 110+ countries), Hungary, Germany, Netherlands, United Kingdom, Finland, Italy, Estonia, Poland, Czech RepublicAcross Europe (part of 110+ countries), Hungary, Germany, Netherlands, United Kingdom, Finland, Italy, Estonia, Poland, Czech Republic
- United States, MexicoUnited States, Mexico
- New ZealandNew Zealand
- ChileChile
- Compliance with ISO 15197:2013 accuracy, hematocrit, and interference standards (CareSens self-blood glucose monitoring system)Compliance with ISO 15197:2013 accuracy, hematocrit, and interference standards (CareSens self-blood glucose monitoring system)
- CE certification obtained (CareSens Air continuous glucose monitoring system)CE certification obtained (CareSens Air continuous glucose monitoring system)
- Designation as an Innovative Medical Device Company (Ministry of Health and Welfare, 2020)Designation as an Innovative Medical Device Company (Ministry of Health and Welfare, 2020)
- Selection as a World-Class Product (Ministry of Trade, Industry and Energy, 2019)Selection as a World-Class Product (Ministry of Trade, Industry and Energy, 2019)
- Acquisition of the first domestic medical device manufacturing license for continuous glucose monitoring systems (June 2023)Acquisition of the first domestic medical device manufacturing license for continuous glucose monitoring systems (June 2023)
- Preparation for US Food and Drug Administration (FDA) approval (clinical trials underway, targeting approval by end of 2026)Preparation for US Food and Drug Administration (FDA) approval (clinical trials underway, targeting approval by end of 2026)