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

- BISTOS Co., Ltd. is a specialized manufacturer of bio-signal diagnostic and therapeutic medical devices. The company offers a diverse product portfolio including fetal monitors, patient monitors, and neonatal phototherapy units. Its core business focuses on providing innovative solutions tailored for obstetrics and neonatology. Recently, the company has expanded its business into the field of neuropsychiatric treatment through the development of brain stimulation devices. BISTOS maintains a global presence, exporting its products to over 120 countries worldwide, establishing itself as a strong small and medium-sized enterprise in the global market.BISTOS Co., Ltd. is a specialized manufacturer of bio-signal diagnostic and therapeutic medical devices. The company offers a diverse product portfolio including fetal monitors, patient monitors, and neonatal phototherapy units. Its core business focuses on providing innovative solutions tailored for obstetrics and neonatology. Recently, the company has expanded its business into the field of neuropsychiatric treatment through the development of brain stimulation devices. BISTOS maintains a global presence, exporting its products to over 120 countries worldwide, establishing itself as a strong small and medium-sized enterprise in the global market.
- Fetal Monitors: Models include BT-350L, 350E, BT-300, BT-250, and BT-220. The BT-350L/E provides fetal heart rate (FHR) and uterine contraction (UC) information via a 7-inch wide TFT-color LCD or LED display. Key features include dual pulsed Doppler, 0.985 MHz ultrasound frequency, an FHR range of 30-240 bpm, automatic detection of dual fetal movement, CTG analysis, cross-channel verification (CCV) for twins, waterproof probes, storage for up to 150 patient data, USB data transfer, and multi-language support.Fetal Monitors: Models include BT-350L, 350E, BT-300, BT-250, and BT-220. The BT-350L/E provides fetal heart rate (FHR) and uterine contraction (UC) information via a 7-inch wide TFT-color LCD or LED display. Key features include dual pulsed Doppler, 0.985 MHz ultrasound frequency, an FHR range of 30-240 bpm, automatic detection of dual fetal movement, CTG analysis, cross-channel verification (CCV) for twins, waterproof probes, storage for up to 150 patient data, USB data transfer, and multi-language support.
- Fetal Dopplers/Ultrasound Doppler Diagnostic Devices: This category includes Hi-bebe Plus, BT-200S, 200L, 200C, 200T, and 200V models. The BT-200L/T offers heart rate and sound measurement with an LCD display and 2MHz/3MHz probes. The BT-220C/L (HiBebe S) features a 2.4-inch TFT color LCD or mono LCD display, a high-sensitivity Doppler probe (2/3MHz), an acoustic stimulator (AST), maternal body fat and heart rate analysis function (BT-220C), mini USB rechargeable capability, and waterproof probes.Fetal Dopplers/Ultrasound Doppler Diagnostic Devices: This category includes Hi-bebe Plus, BT-200S, 200L, 200C, 200T, and 200V models. The BT-200L/T offers heart rate and sound measurement with an LCD display and 2MHz/3MHz probes. The BT-220C/L (HiBebe S) features a 2.4-inch TFT color LCD or mono LCD display, a high-sensitivity Doppler probe (2/3MHz), an acoustic stimulator (AST), maternal body fat and heart rate analysis function (BT-220C), mini USB rechargeable capability, and waterproof probes.
- Patient Monitors: The product line includes BT-750, 700, 740, 770, and 780 models. The BT-770 is equipped with a 12.1-inch full-color touchscreen for measuring essential vital signs such as ECG, respiratory rate, SpO₂, NIBP, and temperature. It supports expansion with optional modules like IBP, CO₂, multi-gas, and cardiac output, offering over 5 hours of battery backup for adult, pediatric, and neonatal monitoring, and compatibility with central monitoring stations.Patient Monitors: The product line includes BT-750, 700, 740, 770, and 780 models. The BT-770 is equipped with a 12.1-inch full-color touchscreen for measuring essential vital signs such as ECG, respiratory rate, SpO₂, NIBP, and temperature. It supports expansion with optional modules like IBP, CO₂, multi-gas, and cardiac output, offering over 5 hours of battery backup for adult, pediatric, and neonatal monitoring, and compatibility with central monitoring stations.
- Neonatal Phototherapy Units: Models BT-400 and BT-450. The BT-400 is a neonatal jaundice treatment device utilizing highly effective blue LED light (450-475 nm peak wavelength). It features a fan-less design for quiet treatment, intensity control (high/low), an extended LED lifetime of over 100,000 hours, display of treatment and total usage time, a built-in clamp for various installation options, and a stand type for neonatal jaundice treatment with a 2.4-inch TFT color LCD display.Neonatal Phototherapy Units: Models BT-400 and BT-450. The BT-400 is a neonatal jaundice treatment device utilizing highly effective blue LED light (450-475 nm peak wavelength). It features a fan-less design for quiet treatment, intensity control (high/low), an extended LED lifetime of over 100,000 hours, display of treatment and total usage time, a built-in clamp for various installation options, and a stand type for neonatal jaundice treatment with a 2.4-inch TFT color LCD display.
- Medical Head Lamps: BT-410, 410A, and 410F models. The BT-410A is a focus-adjustable headlamp providing 50,000lx illumination (with Astral lamp), a color temperature of 6,000K, a long lifespan of 50,000 hours, and a focusing lens size of 20-50mm. It offers comfortable wear, an LED indicator for battery status, and optional shadowless lamp features and a 3.5x magnification loupe.Medical Head Lamps: BT-410, 410A, and 410F models. The BT-410A is a focus-adjustable headlamp providing 50,000lx illumination (with Astral lamp), a color temperature of 6,000K, a long lifespan of 50,000 hours, and a focusing lens size of 20-50mm. It offers comfortable wear, an LED indicator for battery status, and optional shadowless lamp features and a 3.5x magnification loupe.
- Transcutaneous Nerve Stimulator for ADHD: The BT-1000 model. This device offers a safer treatment alternative to drug therapy with fewer side effects. It features an intuitive and detailed display, precise setting ranges and enhanced accuracy, convenient USB-C charging, and a long battery operating time of approximately 24 hours.Transcutaneous Nerve Stimulator for ADHD: The BT-1000 model. This device offers a safer treatment alternative to drug therapy with fewer side effects. It features an intuitive and detailed display, precise setting ranges and enhanced accuracy, convenient USB-C charging, and a long battery operating time of approximately 24 hours.
- Proprietary Bio-Signal Processing Technology: The company possesses unique noise prediction and removal technology for fetal heart rate estimation, ensuring the reliability of fetal monitors. It holds the entire core value chain from basic technology research for bio-signal measurement to product design, manufacturing, and data analysis.Proprietary Bio-Signal Processing Technology: The company possesses unique noise prediction and removal technology for fetal heart rate estimation, ensuring the reliability of fetal monitors. It holds the entire core value chain from basic technology research for bio-signal measurement to product design, manufacturing, and data analysis.
- Extensive Product Lineup and Technological Advancement: BISTOS has established a diverse product portfolio covering the entire life cycle, including fetal and neonatal medical devices, home medical devices, patient monitoring systems, and brain-related medical devices. The company enhances its market competitiveness by upgrading existing flagship products with IoT technology for next-generation solutions.Extensive Product Lineup and Technological Advancement: BISTOS has established a diverse product portfolio covering the entire life cycle, including fetal and neonatal medical devices, home medical devices, patient monitoring systems, and brain-related medical devices. The company enhances its market competitiveness by upgrading existing flagship products with IoT technology for next-generation solutions.
- Global Market Competitiveness and Extensive Regulatory Expertise: A global network with product exports to over 120 countries worldwide. Extensive experience and know-how in international regulatory affairs, including CE certification for 23 products in Europe and FDA product approval for 13 products in the United States.Global Market Competitiveness and Extensive Regulatory Expertise: A global network with product exports to over 120 countries worldwide. Extensive experience and know-how in international regulatory affairs, including CE certification for 23 products in Europe and FDA product approval for 13 products in the United States.
- Continuous R&D and New Growth Engine Acquisition: Expansion into new business areas such as ADHD treatment medical devices, securing patents related to brain stimulation therapy, and pursuing patent registration in the US and China. Technological innovation through the development of neonatal incubators applying AI models and integrated workflow.Continuous R&D and New Growth Engine Acquisition: Expansion into new business areas such as ADHD treatment medical devices, securing patents related to brain stimulation therapy, and pursuing patent registration in the US and China. Technological innovation through the development of neonatal incubators applying AI models and integrated workflow.
- KOSDAQ Listing via SPAC Merger Extinction Method: A unique case of KOSDAQ listing without the extinction of corporate identity and business history, allowing the retention of existing domestic and international permits and approvals.KOSDAQ Listing via SPAC Merger Extinction Method: A unique case of KOSDAQ listing without the extinction of corporate identity and business history, allowing the retention of existing domestic and international permits and approvals.
- Superior Product Quality and User Convenience: Product designs prioritize user convenience for medical professionals and patients, incorporating features such as waterproof probes, fan-less designs, intuitive displays, and various installation options.Superior Product Quality and User Convenience: Product designs prioritize user convenience for medical professionals and patients, incorporating features such as waterproof probes, fan-less designs, intuitive displays, and various installation options.
- Obstetrics and Gynecology: A primary application area for fetal monitors and fetal dopplers.Obstetrics and Gynecology: A primary application area for fetal monitors and fetal dopplers.
- Pediatrics and Neonatology: Key application fields for neonatal phototherapy units, infant incubators, and infant warmers.Pediatrics and Neonatology: Key application fields for neonatal phototherapy units, infant incubators, and infant warmers.
- General Hospitals and Clinics: Utilization of patient monitors, medical headlamps, and infrared thermometers in various medical settings.General Hospitals and Clinics: Utilization of patient monitors, medical headlamps, and infrared thermometers in various medical settings.
- Home Healthcare Market: Provision of home healthcare products such as electric breast pumps and fetal dopplers.Home Healthcare Market: Provision of home healthcare products such as electric breast pumps and fetal dopplers.
- Emergency Medical Services: Supply of vital sign monitoring equipment for emergency situations.Emergency Medical Services: Supply of vital sign monitoring equipment for emergency situations.
- Operating Rooms and Intensive Care Units: Provision of equipment for environments requiring precise patient monitoring.Operating Rooms and Intensive Care Units: Provision of equipment for environments requiring precise patient monitoring.
- Mental Health Sector: Entry into the neuropsychiatric treatment market through the development of ADHD treatment medical devices.Mental Health Sector: Entry into the neuropsychiatric treatment market through the development of ADHD treatment medical devices.
- South Korea, China, Asia regionSouth Korea, China, Asia region
- Europe regionEurope region
- United StatesUnited States
- Central and South AmericaCentral and South America
- Total of 27 Patents: Possession of 27 patents, including 23 original technology patents related to bio-signal measurement and analysis.Total of 27 Patents: Possession of 27 patents, including 23 original technology patents related to bio-signal measurement and analysis.
- Fetal Heartbeat Verification Signal Processing Patent: Domestic patent registration for a method of fetal heartbeat verification signal processing in ultrasonic Doppler fetal monitors (related to CCV, CTG).Fetal Heartbeat Verification Signal Processing Patent: Domestic patent registration for a method of fetal heartbeat verification signal processing in ultrasonic Doppler fetal monitors (related to CCV, CTG).
- Breast Pump Control System Patent: Domestic patent registration for a breast pump control system and method using voice recognition.Breast Pump Control System Patent: Domestic patent registration for a breast pump control system and method using voice recognition.
- US Patent Registration: One US patent registered for fetal heartbeat detection signal processing in ultrasonic Doppler fetal monitors.US Patent Registration: One US patent registered for fetal heartbeat detection signal processing in ultrasonic Doppler fetal monitors.
- ADHD Treatment Device Related Patents: Domestic patent registration for electrostimulation devices and ongoing efforts for patent registration in the US and China.ADHD Treatment Device Related Patents: Domestic patent registration for electrostimulation devices and ongoing efforts for patent registration in the US and China.
- European CE Certification: Acquired CE marking for 23 products for market entry in Europe.European CE Certification: Acquired CE marking for 23 products for market entry in Europe.
- US FDA Product Approval: Secured product approval from the US Food and Drug Administration (FDA) for 13 products.US FDA Product Approval: Secured product approval from the US Food and Drug Administration (FDA) for 13 products.
- Domestic KFDA Certification: Acquired certification from the Korea Ministry of Food and Drug Safety (KFDA) for products such as the BT-400 neonatal phototherapy unit.Domestic KFDA Certification: Acquired certification from the Korea Ministry of Food and Drug Safety (KFDA) for products such as the BT-400 neonatal phototherapy unit.
- International Quality Management System Certifications: Obtained ISO9001, EN46001, and ISO13485 certifications, demonstrating excellence in quality management systems.International Quality Management System Certifications: Obtained ISO9001, EN46001, and ISO13485 certifications, demonstrating excellence in quality management systems.
- CMDCAS Certification: Acquired Canadian Medical Device Conformity Assessment System (CMDCAS) certification.CMDCAS Certification: Acquired Canadian Medical Device Conformity Assessment System (CMDCAS) certification.