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

- MEDIANA Co., Ltd. is a leading South Korean medical device company established in 1995, specializing in the development and manufacturing of patient monitoring devices, automated external defibrillators (AEDs), and other medical measuring instruments. The company supplies its products to approximately 80 countries worldwide, demonstrating strong global competitiveness. MEDIANA's technological prowess is recognized through its ODM (Original Development Manufacturing) partnerships with global medical device companies like Medtronic and Siemens. Recently, the company has been focusing on integrating artificial intelligence (AI) technology into its medical devices to develop next-generation solutions for predicting patient deterioration, thus leading innovation in the digital healthcare sector.MEDIANA Co., Ltd. is a leading South Korean medical device company established in 1995, specializing in the development and manufacturing of patient monitoring devices, automated external defibrillators (AEDs), and other medical measuring instruments. The company supplies its products to approximately 80 countries worldwide, demonstrating strong global competitiveness. MEDIANA's technological prowess is recognized through its ODM (Original Development Manufacturing) partnerships with global medical device companies like Medtronic and Siemens. Recently, the company has been focusing on integrating artificial intelligence (AI) technology into its medical devices to develop next-generation solutions for predicting patient deterioration, thus leading innovation in the digital healthcare sector.
- Patient Monitoring Devices (PMD): Essential equipment for real-time measurement and analysis of various vital signs such as ECG, NIBP, SpO2, respiration, and temperature, providing critical information to medical professionals. Key models include M50, M30, M20, YM1000, and the YM9000 series. The PM10N, in particular, is a portable pulse oximetry system compatible with Nellcor Oximax technology, suitable for adult, pediatric, and neonatal patients. The M50S model integrates ultrasound patient monitoring capabilities.Patient Monitoring Devices (PMD): Essential equipment for real-time measurement and analysis of various vital signs such as ECG, NIBP, SpO2, respiration, and temperature, providing critical information to medical professionals. Key models include M50, M30, M20, YM1000, and the YM9000 series. The PM10N, in particular, is a portable pulse oximetry system compatible with Nellcor Oximax technology, suitable for adult, pediatric, and neonatal patients. The M50S model integrates ultrasound patient monitoring capabilities.
- Automated External Defibrillators (AED): Emergency medical devices designed to resuscitate patients experiencing cardiac arrest through electrical shocks. The product lineup includes models such as A15, A16, D100, D500, D700, T15, and T16. The A16 model notably received Europe's CE MDR certification as the first in Asia. The D500 is a professional-grade multifunctional defibrillator/monitor featuring manual and AED modes, non-invasive pacing, 12-lead ECG monitoring, dual rechargeable batteries, and a remote management system.Automated External Defibrillators (AED): Emergency medical devices designed to resuscitate patients experiencing cardiac arrest through electrical shocks. The product lineup includes models such as A15, A16, D100, D500, D700, T15, and T16. The A16 model notably received Europe's CE MDR certification as the first in Asia. The D500 is a professional-grade multifunctional defibrillator/monitor featuring manual and AED modes, non-invasive pacing, 12-lead ECG monitoring, dual rechargeable batteries, and a remote management system.
- Central Patient Monitoring System (CMS): A software solution that integrates and monitors data from multiple patient monitoring devices in real-time, enhancing medical staff's work efficiency and patient safety.Central Patient Monitoring System (CMS): A software solution that integrates and monitors data from multiple patient monitoring devices in real-time, enhancing medical staff's work efficiency and patient safety.
- Automatic CPR Machine: MEDIANA has acquired technology and patents related to automatic chest compression devices, which perform chest compressions at a consistent rate and pressure for cardiac arrest patients, strengthening its position as a leader in the emergency medical market.Automatic CPR Machine: MEDIANA has acquired technology and patents related to automatic chest compression devices, which perform chest compressions at a consistent rate and pressure for cardiac arrest patients, strengthening its position as a leader in the emergency medical market.
- Global ODM and Own-Brand Competitiveness: The company supplies products on an ODM basis to world-renowned medical device companies like Medtronic and Siemens, while also exporting its own-brand products to over 80 countries globally, establishing a strong international presence.Global ODM and Own-Brand Competitiveness: The company supplies products on an ODM basis to world-renowned medical device companies like Medtronic and Siemens, while also exporting its own-brand products to over 80 countries globally, establishing a strong international presence.
- Innovative R&D Capabilities and AI Convergence Technology: MEDIANA pursues continuous technological innovation through knowledge-based production strategies and strengthened R&D competitiveness, focusing on developing AI-based patient deterioration prediction solutions in collaboration with Selvas AI, thereby leading the digital healthcare sector.Innovative R&D Capabilities and AI Convergence Technology: MEDIANA pursues continuous technological innovation through knowledge-based production strategies and strengthened R&D competitiveness, focusing on developing AI-based patient deterioration prediction solutions in collaboration with Selvas AI, thereby leading the digital healthcare sector.
- Extensive International Certifications and Patents: The company was the first in Korea to obtain Europe's CE MDR certification for its AED and PMD/CMS models, meeting stringent safety and quality standards for the European market. It also holds numerous international certifications including ISO13485, MDSAP, FDA, CB scheme, and UL. With 47 patents, including a European patent for an 'automatic cardiopulmonary resuscitation device' and the acquisition of automatic chest compression device technology, MEDIANA maintains a strong technological edge.Extensive International Certifications and Patents: The company was the first in Korea to obtain Europe's CE MDR certification for its AED and PMD/CMS models, meeting stringent safety and quality standards for the European market. It also holds numerous international certifications including ISO13485, MDSAP, FDA, CB scheme, and UL. With 47 patents, including a European patent for an 'automatic cardiopulmonary resuscitation device' and the acquisition of automatic chest compression device technology, MEDIANA maintains a strong technological edge.
- Broad Domestic and International Distribution Network and Customer Base: MEDIANA has secured a dominant market position by supplying wired patient monitoring devices to approximately 3,000 hospitals, including major domestic hospitals and university hospitals, as well as public facilities like Seoul subways and military units. Internationally, its products are used in prestigious institutions such as Harvard University Hospital, Johns Hopkins University Hospital (USA), and Tokyo University Hospital (Japan).Broad Domestic and International Distribution Network and Customer Base: MEDIANA has secured a dominant market position by supplying wired patient monitoring devices to approximately 3,000 hospitals, including major domestic hospitals and university hospitals, as well as public facilities like Seoul subways and military units. Internationally, its products are used in prestigious institutions such as Harvard University Hospital, Johns Hopkins University Hospital (USA), and Tokyo University Hospital (Japan).
- Establishment of Wired and Wireless Integrated Monitoring Solutions: By combining its strengths in the existing wired patient monitoring market with wearable ECG technology, MEDIANA is building Korea's first wired and wireless integrated monitoring system. This addresses the growing need for managing moderate-to-mild and mobile patients.Establishment of Wired and Wireless Integrated Monitoring Solutions: By combining its strengths in the existing wired patient monitoring market with wearable ECG technology, MEDIANA is building Korea's first wired and wireless integrated monitoring system. This addresses the growing need for managing moderate-to-mild and mobile patients.
- Hospitals and Medical Institutions: Utilized as essential equipment for vital sign monitoring and emergency treatment in operating rooms, intensive care units, emergency rooms, and general wards.Hospitals and Medical Institutions: Utilized as essential equipment for vital sign monitoring and emergency treatment in operating rooms, intensive care units, emergency rooms, and general wards.
- Emergency Medical Services: Employed in emergency settings such as ambulances and fire departments for real-time transmission of patient vital signs during transport and support for cardiopulmonary resuscitation.Emergency Medical Services: Employed in emergency settings such as ambulances and fire departments for real-time transmission of patient vital signs during transport and support for cardiopulmonary resuscitation.
- Public Spaces and Facilities: Automated External Defibrillators (AEDs) are installed in public areas like large shopping malls, subway stations, and community centers for use by the general public in emergency situations.Public Spaces and Facilities: Automated External Defibrillators (AEDs) are installed in public areas like large shopping malls, subway stations, and community centers for use by the general public in emergency situations.
- Homecare and Telemedicine: Portable pulse oximeters (PM10N) and similar products can be used for patient monitoring in home settings.Homecare and Telemedicine: Portable pulse oximeters (PM10N) and similar products can be used for patient monitoring in home settings.
- Japan, China, South Korea (Domestic)Japan, China, South Korea (Domestic)
- United Kingdom, Turkey, European Economic Area (EEA), Switzerland, EU 27 countriesUnited Kingdom, Turkey, European Economic Area (EEA), Switzerland, EU 27 countries
- United States, CanadaUnited States, Canada
- AustraliaAustralia
- BrazilBrazil
- European CE MDR Certification: Obtained CE MDR (Medical Device Regulation) certification for all models of Patient Monitoring Devices (PMD), Central Patient Monitoring System (CMS), and AED models A15 and A16, establishing a foundation for entry into the European market.European CE MDR Certification: Obtained CE MDR (Medical Device Regulation) certification for all models of Patient Monitoring Devices (PMD), Central Patient Monitoring System (CMS), and AED models A15 and A16, establishing a foundation for entry into the European market.
- US FDA Approval: Received US FDA approval for patient monitoring device models PM100N, V10, and V20, ensuring product reliability in the North American market.US FDA Approval: Received US FDA approval for patient monitoring device models PM100N, V10, and V20, ensuring product reliability in the North American market.
- International Quality Management System Certifications: Acquired ISO13485:2016 / EN ISO13485:2016 certification for medical device quality management systems from BSI. Also holds MDSAP ISO13485:2016 certification, a single audit program for medical device quality management in the US, Australia, Canada, Brazil, and Japan.International Quality Management System Certifications: Acquired ISO13485:2016 / EN ISO13485:2016 certification for medical device quality management systems from BSI. Also holds MDSAP ISO13485:2016 certification, a single audit program for medical device quality management in the US, Australia, Canada, Brazil, and Japan.
- Electrical Safety and Conformity Certifications: Possesses a CB scheme certificate for electrical equipment standard conformity testing and a UL certificate, meeting the safety consensus standards of Nationally Recognized Testing Laboratories (NRTL).Electrical Safety and Conformity Certifications: Possesses a CB scheme certificate for electrical equipment standard conformity testing and a UL certificate, meeting the safety consensus standards of Nationally Recognized Testing Laboratories (NRTL).
- Patent Holdings: Holds 47 patents, including a European patent for an 'automatic cardiopulmonary resuscitation device,' and has acquired all related technology and patents for automatic chest compression devices, strengthening its technological competitiveness.Patent Holdings: Holds 47 patents, including a European patent for an 'automatic cardiopulmonary resuscitation device,' and has acquired all related technology and patents for automatic chest compression devices, strengthening its technological competitiveness.