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

- I-SENS Co., Ltd. is a global in-vitro diagnostics specialist company contributing to human health based on advanced biosensor and electrochemical technology. The company possesses capabilities in developing and manufacturing various medical devices, including self-blood glucose meters, continuous glucose monitors, and blood analysis systems. Exporting products to over 110 countries worldwide, it reinforces its position as a global healthcare leader. I-SENS leads innovation through the launch of 'CareSens Air,' Korea's first continuous glucose monitor. Continuous research and development, along with investment in core technologies, drive its efforts to supply world-class products.I-SENS Co., Ltd. is a global in-vitro diagnostics specialist company contributing to human health based on advanced biosensor and electrochemical technology. The company possesses capabilities in developing and manufacturing various medical devices, including self-blood glucose meters, continuous glucose monitors, and blood analysis systems. Exporting products to over 110 countries worldwide, it reinforces its position as a global healthcare leader. I-SENS leads innovation through the launch of 'CareSens Air,' Korea's first continuous glucose monitor. Continuous research and development, along with investment in core technologies, drive its efforts to supply world-class products.
- **Self-Blood Glucose Meters (CareSens Series)**: A broad lineup of models including CareSens N, CareSens N NFC, CareSens N Voice, CareSens N POP, CareSens N Premier, CareSens N Messenger, CareSens PRO, CareSens Dual, CareSens II, and CareSens II Plus. Technology capable of measuring blood glucose within 5 seconds with an ultra-small blood sample of 0.5㎕. A highly reliable measurement system meeting the accuracy standards of ISO 15197:2013. Provision of data management convenience through Bluetooth connectivity and smartphone applications.**Self-Blood Glucose Meters (CareSens Series)**: A broad lineup of models including CareSens N, CareSens N NFC, CareSens N Voice, CareSens N POP, CareSens N Premier, CareSens N Messenger, CareSens PRO, CareSens Dual, CareSens II, and CareSens II Plus. Technology capable of measuring blood glucose within 5 seconds with an ultra-small blood sample of 0.5㎕. A highly reliable measurement system meeting the accuracy standards of ISO 15197:2013. Provision of data management convenience through Bluetooth connectivity and smartphone applications.
- **Continuous Glucose Monitors (CareSens Air Series)**: The 'CareSens Air' model, launched as Korea's first continuous glucose monitor in September 2023. Technology for 24-hour real-time blood glucose monitoring via a skin-inserted sensor. A precise and proactive blood glucose management solution, including blood glucose trend analysis and emergency alerts. User convenience with a 15-day usage period and optional calibration.**Continuous Glucose Monitors (CareSens Air Series)**: The 'CareSens Air' model, launched as Korea's first continuous glucose monitor in September 2023. Technology for 24-hour real-time blood glucose monitoring via a skin-inserted sensor. A precise and proactive blood glucose management solution, including blood glucose trend analysis and emergency alerts. User convenience with a 15-day usage period and optional calibration.
- **Point-of-Care Testing (POCT) and Blood Analysis Systems**: A specialized portfolio for hospital and diagnostic markets, including glycohemoglobin analyzers, blood gas analyzers, and medical electrode electrolyte analyzers. Contribution to the animal healthcare sector through 'VetMate®' (an animal-specific blood glucose meter) and animal electrolyte analyzers. High-precision analysis capabilities based on advanced biosensor and electrochemical technologies.**Point-of-Care Testing (POCT) and Blood Analysis Systems**: A specialized portfolio for hospital and diagnostic markets, including glycohemoglobin analyzers, blood gas analyzers, and medical electrode electrolyte analyzers. Contribution to the animal healthcare sector through 'VetMate®' (an animal-specific blood glucose meter) and animal electrolyte analyzers. High-precision analysis capabilities based on advanced biosensor and electrochemical technologies.
- **Global Market Leadership**: A strong position as a global in-vitro diagnostics company, exporting products to over 110 countries worldwide. High product recognition and reliability secured in advanced markets such as the US, Europe, and Japan. Market penetration strategies through the establishment of overseas subsidiaries and local production.**Global Market Leadership**: A strong position as a global in-vitro diagnostics company, exporting products to over 110 countries worldwide. High product recognition and reliability secured in advanced markets such as the US, Europe, and Japan. Market penetration strategies through the establishment of overseas subsidiaries and local production.
- **Proprietary Biosensor Technology**: Capabilities in developing and producing accurate and reliable blood glucose meters based on electrochemical biosensor technology. World-class technology achieving small blood sample volumes of 0.5㎕ and measurement speeds of 5 seconds. Continuous research and development for technological innovation and patent acquisition.**Proprietary Biosensor Technology**: Capabilities in developing and producing accurate and reliable blood glucose meters based on electrochemical biosensor technology. World-class technology achieving small blood sample volumes of 0.5㎕ and measurement speeds of 5 seconds. Continuous research and development for technological innovation and patent acquisition.
- **Innovative Product Portfolio Expansion**: A leader in the self-blood glucose meter market, launching 'CareSens Air' as the first continuous glucose monitor in Korea. Ongoing investment in next-generation CGM model development and global market expansion. A comprehensive product range covering hospital point-of-care diagnostic devices and animal medical devices.**Innovative Product Portfolio Expansion**: A leader in the self-blood glucose meter market, launching 'CareSens Air' as the first continuous glucose monitor in Korea. Ongoing investment in next-generation CGM model development and global market expansion. A comprehensive product range covering hospital point-of-care diagnostic devices and animal medical devices.
- **User-Centric Convenience and Quality**: Product design maximizing user convenience, including Bluetooth connectivity, smartphone app integration, and voice guidance. Compliance with stringent domestic and international quality standards such as ISO 15197:2013, CE Mark, and FDA approval. Proven consumer trust evidenced by 13 consecutive 'Brand of the Year Awards'.**User-Centric Convenience and Quality**: Product design maximizing user convenience, including Bluetooth connectivity, smartphone app integration, and voice guidance. Compliance with stringent domestic and international quality standards such as ISO 15197:2013, CE Mark, and FDA approval. Proven consumer trust evidenced by 13 consecutive 'Brand of the Year Awards'.
- **Vertical Integration and Production Efficiency**: Operation of the Wonju factory for strip production and the Songdo 2nd factory equipped with automated CGM production lines. Securing an annual CGM production capacity of over 2 million units and efforts to enhance yield. Low sensitivity to raw material price fluctuations and a stable revenue structure from consumables (strips).**Vertical Integration and Production Efficiency**: Operation of the Wonju factory for strip production and the Songdo 2nd factory equipped with automated CGM production lines. Securing an annual CGM production capacity of over 2 million units and efforts to enhance yield. Low sensitivity to raw material price fluctuations and a stable revenue structure from consumables (strips).
- Personal healthcare industry (self-blood glucose management, continuous glucose monitoring)Personal healthcare industry (self-blood glucose management, continuous glucose monitoring)
- Hospital and clinical diagnostics industry (blood gas, electrolyte, glycated hemoglobin analysis)Hospital and clinical diagnostics industry (blood gas, electrolyte, glycated hemoglobin analysis)
- Animal healthcare industry (pet blood glucose and electrolyte management)Animal healthcare industry (pet blood glucose and electrolyte management)
- Digital healthcare industry (smartphone app integration, data-driven health management solutions)Digital healthcare industry (smartphone app integration, data-driven health management solutions)
- Middle East and some African countriesMiddle East and some African countries
- Japan, China, India, Malaysia, Southeast Asian countries, Israel, TurkeyJapan, China, India, Malaysia, Southeast Asian countries, Israel, Turkey
- Germany, UK, France, Italy, Spain, Switzerland, Finland, HungaryGermany, UK, France, Italy, Spain, Switzerland, Finland, Hungary
- USA, CanadaUSA, Canada
- New Zealand, AustraliaNew Zealand, Australia
- Chile, MexicoChile, Mexico
- ISO 13485 (Medical Device Quality Management System) certification.ISO 13485 (Medical Device Quality Management System) certification.
- CE Mark (European Medical Device Directive) and US FDA approval.CE Mark (European Medical Device Directive) and US FDA approval.
- Protection of core technologies through over 250 domestic and international patent applications and registrations.Protection of core technologies through over 250 domestic and international patent applications and registrations.
- Possession of multiple core patents related to electrochemical biosensor technology.Possession of multiple core patents related to electrochemical biosensor technology.
- Compliance of self-blood glucose monitoring systems with ISO 15197:2013 accuracy, hematocrit, and interference criteria.Compliance of self-blood glucose monitoring systems with ISO 15197:2013 accuracy, hematocrit, and interference criteria.