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

- A specialized enterprise in the development and manufacturing of various biosignal diagnostic medical devices, including patient and fetal monitors, electrocardiographs, and animal diagnostic equipment.A specialized enterprise in the development and manufacturing of various biosignal diagnostic medical devices, including patient and fetal monitors, electrocardiographs, and animal diagnostic equipment.
- Development and manufacturing capabilities for diverse biosignal diagnostic devices such as Patient Monitors (BPM-1200 PATRON, BPM-1010 MATRON, BPM-1000 MATRON, BPM-770 GUARDIAN, BPM-190 SENTRY PLUS, PalmCare plus), Fetal Monitors (BFM-900L, BFM-900), and Electrocardiographs (BCM-600, BCM-300).Development and manufacturing capabilities for diverse biosignal diagnostic devices such as Patient Monitors (BPM-1200 PATRON, BPM-1010 MATRON, BPM-1000 MATRON, BPM-770 GUARDIAN, BPM-190 SENTRY PLUS, PalmCare plus), Fetal Monitors (BFM-900L, BFM-900), and Electrocardiographs (BCM-600, BCM-300).
- Possession of network solutions and AI-based technologies, including AI CMS for 40-BED real-time central monitoring and N-marker, an AI program for disease diagnosis and abnormal sign detection.Possession of network solutions and AI-based technologies, including AI CMS for 40-BED real-time central monitoring and N-marker, an AI program for disease diagnosis and abnormal sign detection.
- Years of expertise and product diversity: Successful development and manufacturing of over 10 types of medical devices based on accumulated know-how in patient and fetal monitoring since its establishment in 2004.Years of expertise and product diversity: Successful development and manufacturing of over 10 types of medical devices based on accumulated know-how in patient and fetal monitoring since its establishment in 2004.
- Global quality standards and certifications: Establishment of international quality management systems such as MDD and ISO 13485, and acquisition of CE Mark for the European market, demonstrating adherence to strict quality criteria.Global quality standards and certifications: Establishment of international quality management systems such as MDD and ISO 13485, and acquisition of CE Mark for the European market, demonstrating adherence to strict quality criteria.
- Extensive domestic and international distribution network: Efforts to expand overseas markets through over 50 distributors and 4 exclusive distributors worldwide, along with a nationwide network for the domestic market.Extensive domestic and international distribution network: Efforts to expand overseas markets through over 50 distributors and 4 exclusive distributors worldwide, along with a nationwide network for the domestic market.
- Development of AI-based solutions: Securing future growth engines through the development of innovative network solutions and AI technologies like the central monitoring system (AI CMS) and disease diagnosis AI program (N-marker).Development of AI-based solutions: Securing future growth engines through the development of innovative network solutions and AI technologies like the central monitoring system (AI CMS) and disease diagnosis AI program (N-marker).
- Price competitiveness and service: Provision of competitive pricing policies and comprehensive services alongside a diverse product range for enhanced customer satisfaction.Price competitiveness and service: Provision of competitive pricing policies and comprehensive services alongside a diverse product range for enhanced customer satisfaction.
- Application in the human medical diagnostic industryApplication in the human medical diagnostic industry
- Provision of solutions for the veterinary medical diagnostic industryProvision of solutions for the veterinary medical diagnostic industry
- Utilization in hospitals and clinics for patient monitoring and electrocardiogram diagnosisUtilization in hospitals and clinics for patient monitoring and electrocardiogram diagnosis
- Supply of fetal monitoring equipment in the obstetrics and gynecology sectorSupply of fetal monitoring equipment in the obstetrics and gynecology sector
- South AfricaSouth Africa
- India, China (FDA/SFDA application planned), Middle East regionIndia, China (FDA/SFDA application planned), Middle East region
- Germany, Italy, Russia and other European countriesGermany, Italy, Russia and other European countries
- Preparation for FDA certification application for North American market entryPreparation for FDA certification application for North American market entry
- Acquisition of international quality management system certifications ISO 13485 and MDD.Acquisition of international quality management system certifications ISO 13485 and MDD.
- Obtainment of CE Mark for entry into the European market.Obtainment of CE Mark for entry into the European market.
- Planned applications for FDA certification for the North American market and SFDA certification for the Chinese market.Planned applications for FDA certification for the North American market and SFDA certification for the Chinese market.