Medical AI Alliance
← Company Index
Medical DevicesKOSDAQ 41954075 approvals

Bistos Co., Ltd.

Official website

Founded in 2001 and KOSDAQ-listed in 2022, Bistos manufactures fetal, neonatal, and patient monitoring medical devices.

Price

Change

Market cap

Business overview

Source: DART corporate disclosure

Founded in 2001 and listed on KOSDAQ in 2022, Bistos is a fetal, neonatal, and patient-monitoring medical device company. It offers the BT200 fetal heart rate monitor, the BT300 fetal monitor, the higher-end BT350, neonatal products such as incubators, warmers, and phototherapy units, patient monitoring devices including SpO2 monitors, and home medical devices such as the BT100 breast pump and thermometers. It exports to about 120 countries, generating over 90% of sales from overseas, has an exclusive breast pump distribution agreement with Motif in the US, and its BT200 fetal heart rate monitor has captured more than 60% of the Indonesian market.

Products & technology

  • BT300 fetal monitorFetal monitoring
  • BT200 fetal heart rate monitorFetal heart rate measurement (including home use)
  • BT350LCD display-based higher-end fetal heart rate monitor
  • Neonatal products (incubator, warmer, phototherapy unit)Neonatal care
  • BT100 breast pumpHome-use breast pump
  • Patient monitors (SpO2 monitor, multi-function patient monitor, central monitoring S/W)Patient vital sign monitoring
  • Ultrasound blood flow monitor, headlampDerivative specialty products
  • ThermometerHome medical device
  • BT2000 Baby Monitor24-hour infant behavior/sleep monitoring to prevent sudden infant death
  • BT650 ECG MachinePhysiological function test recording ECG waveforms

Regulatory approvals

data.go.kr · openFDA

70 Korean MFDS device approvals · 2002–2026 / 5 US FDA 510(k) · 2016–2025

  • MFDSAnalyser, physiologic, obstetrical data, perinatal2026-08-04
    Product approval · Class 2제인 26-4723 호
  • FDAHi bebe super (BT-150B)2025-09-25
    510(k) · SpecialObstetrics/GynecologyK251512
  • MFDSPulse oximeter, line-powered2025-04-04
    Product approval · Class 2제인 25-4285 호
  • MFDSAnalyser, physiologic, obstetrical data, perinatal2025-03-27
    Product approval · Class 2제인 25-4248 호
  • MFDSHeater, infant2025-03-10
    Product approval · Class 2제인 25-4184 호
  • MFDSAnalyser, physiologic, obstetrical data, perinatal2025-01-22
    Product approval · Class 2제인 25-4084 호
  • MFDSSoftware for general hospital2024-09-12
    Product approval · Class 2제허 24-634 호
  • FDABT-10002024-08-28
    510(k) · TraditionalNeurologyK232991
  • MFDSPulse oximeter, line-powered2024-07-02
    Product approval · Class 2제인 24-649 호
  • MFDSMedical image, analog to digital transform, DR, CR2024-04-09
    Product approval · Class 2제인 24-375 호
  • MFDSPulse oximeter, line-poweredRevoked2023-10-11
    Product approval · Class 2제인 23-5152 호
  • MFDSBrain electrical stimulation system, psychiatric therapy2023-09-11
    Product approval · Class 3제허 23-907 호
Show 63 more
  • MFDSAnalyser, physiologic, obstetrical data, perinatal2023-02-28
    Product approval · Class 2제인 23-4211 호
  • MFDSPump, breast, electrically-powered2023-01-27
    Product approval · Class 2제인 23-4101 호
  • MFDSAnalyser, physiologic, obstetrical data, perinatalRevoked2022-08-25
    Product approval · Class 2제인 22-4627 호
  • MFDSIncubator, infantRevoked2022-08-09
    Product approval · Class 3제허 22-538 호
  • MFDSMonitor, phonocardiographic, fetalRevoked2022-06-22
    Product approval · Class 2제인 22-4471 호
  • MFDSHeater, infantRevoked2022-06-22
    Product approval · Class 2제인 22-4470 호
  • MFDSThermometer, electronic, infrared, skin2022-03-17
    Product approval · Class 2제인 22-4214 호
  • MFDSPatient monitorRevoked2022-03-08
    Product approval · Class 2제인 22-4187 호
  • MFDSPatient monitorRevoked2021-09-09
    Product approval · Class 2제인 21-4794 호
  • MFDSThermometer, electronic, infrared, skinRevoked2021-08-17
    Product approval · Class 2제인 21-4707 호
  • MFDSPediatric phototherapy unit2021-06-22
    Product approval · Class 2제인 21-4541 호
  • FDAInfant Phototherapy Equipment2021-05-28
    510(k) · TraditionalGeneral HospitalK210289
  • MFDSPatient monitor2021-03-03
    Product approval · Class 2제허 21-163 호
  • FDAHi bebe super (Models BT-150S and BT-150L)2021-02-10
    510(k) · SpecialObstetrics/GynecologyK200675
  • MFDSPediatric phototherapy unit2020-12-21
    Product approval · Class 2제인 20-5126 호
  • MFDSPediatric phototherapy unitRevoked2020-10-21
    Product approval · Class 2제인 20-4953 호
  • MFDSPatient monitorRevoked2020-03-11
    Product approval · Class 2제인 20-4193 호
  • MFDSPediatric phototherapy unit2019-09-09
    Product approval · Class 2제인 19-4769 호
  • MFDSPump, breast, electrically-powered2019-07-03
    Product approval · Class 2제인 19-4541 호
  • MFDSPulse oximeter, line-powered2018-12-03
    Product approval · Class 2제허 18-766 호
  • MFDSPatient monitor2018-10-30
    Product approval · Class 2제허 18-710 호
  • MFDSPatient monitorRevoked2018-08-24
    Product approval · Class 2제인 18-4676 호
  • MFDSPump, breast, electrically-poweredRevoked2018-08-24
    Product approval · Class 2제인 18-4674 호
  • MFDSPatient monitorRevoked2018-07-16
    Product approval · Class 2제인 18-4555 호
  • MFDSPatient monitorRevoked2017-07-05
    Product approval · Class 2제인 17-4541 호
  • MFDSPatient monitorRevoked2017-07-05
    Product approval · Class 2제인 17-4540 호
  • MFDSPatient monitorRevoked2017-07-05
    Product approval · Class 2제인 17-4539 호
  • MFDSPulse oximeter, line-poweredRevoked2017-07-04
    Product approval · Class 2제인 17-4532 호
  • FDAHi bebe plus2016-09-01
    510(k) · TraditionalObstetrics/GynecologyK160274
  • MFDSPump, breast, electrically-powered2015-10-26
    Product approval · Class 2제인 15-4220 호
  • MFDSHeater, infant2015-09-08
    Product approval · Class 2제인 15-4116 호
  • MFDSPump, breast, electrically-poweredRevoked2015-07-01
    Product approval · Class 2제인 15-1062 호
  • MFDSHeater, infantRevoked2015-06-22
    Product approval · Class 2제인 15-985 호
  • MFDSHigh intensity focused Ultrasonic surgical systemRevoked2014-07-02
    Product approval · Class 3제허 14-1251 호
  • MFDSHigh intensity focused Ultrasonic surgical systemRevoked2014-03-13
    Product approval · Class 3제허 14-630 호
  • MFDSAnalyser, physiologic, obstetrical data, perinatal2013-11-08
    Product approval · Class 2제인 13-1901 호
  • MFDSIncubator, infant2013-05-06
    Product approval · Class 3제허 13-801 호
  • MFDSAnalyser, physiologic, obstetrical data, perinatal2013-04-10
    Product approval · Class 2제인 13-666 호
  • MFDSMonitor, ultrasonic, fetal2013-02-18
    Product approval · Class 2제인 13-391 호
  • MFDSMonitor, ultrasonic, fetalRevoked2013-02-01
    Product approval · Class 2제인 13-319 호
  • MFDSPatient monitorRevoked2012-06-20
    Product approval · Class 2제인 12-792 호
  • MFDSMonitor, ultrasonic, fetalRevoked2012-05-25
    Product approval · Class 2제허 12-664 호
  • MFDSMonitor, ultrasonic, fetalRevoked2012-05-25
    Product approval · Class 2제허 12-665 호
  • MFDSIncubator, infantRevoked2012-05-14
    Product approval · Class 3제허 12-609 호
  • MFDSPatient monitorRevoked2012-02-06
    Product approval · Class 2제인 12-154 호
  • MFDSMonitor, ultrasonic, fetalRevoked2010-10-07
    Product approval · Class 2제인 10-1025 호
  • MFDSPatient monitorRevoked2010-05-19
    Product approval · Class 2제허 10-497 호
  • MFDSMonitor, phonocardiographic, fetal2010-05-19
    Product approval · Class 2제인 10-496 호
  • MFDSLight, head-worn2010-04-13
    Product approval · Class 1서울 제신 10-61 호
  • MFDSAnalyser, physiologic, obstetrical data, perinatal2009-10-07
    Product approval · Class 2제인 09-825 호
  • MFDSMonitor, phonocardiographic, fetal2009-09-29
    Product approval · Class 2제인 09-809 호
  • MFDS환자감시장치Revoked2009-05-12
    Product approval · Class 2제인 09-368 호
  • MFDSMonitor, phonocardiographic, fetalRevoked2009-03-16
    Product approval · Class 2제인 09-173 호
  • MFDSAnalyser, physiologic, obstetrical data, perinatal2008-05-23
    Product approval · Class 2제인 08-316 호
  • MFDSPediatric phototherapy unitRevoked2008-04-23
    Product approval · Class 2제인 08-223 호
  • MFDS분만감시장치Revoked2007-06-04
    Product approval · Class 2제허 07-307 호
  • MFDSBlood flow measurement ultrasound system2007-01-31
    Product approval · Class 2제인 07-57 호
  • MFDS초음파영상진단장치Revoked2006-09-05
    Product approval · Class 3제허 06-641 호
  • MFDS분만감시장치Revoked2006-05-25
    Product approval · Class 2제허 06-367 호
  • MFDSMonitor, phonocardiographic, fetalRevoked2004-10-05
    Product approval · Class 2제인 04-1025 호
  • MFDS분만감시장치Revoked2004-10-05
    Product approval · Class 2제허 04-1038 호
  • MFDSMonitor, phonocardiographic, fetal2004-02-04
    Product approval · Class 2제인 04-116 호
  • MFDSAnalyser, physiologic, obstetrical data, perinatalRevoked2002-06-08
    Product approval · Class 2제인 02-480 호

R&D and key agreements

Source: DART corporate disclosure

BT2000 Baby Monitor · 영아 돌연사 예방 · 개발중(2023.10~2025.06) · Uses IR video to analyze infant behavior, activity, sleep quality, and sound for 24-hour monitoring

BT650 ECG Machine · 심장질환 진단 · 개발중(2025.01~2026.06) · Developing a physiological function test device with resting ECG, stress ECG, and Holter monitoring capabilities

Not yet compiled: business overview. Send us materials and we will add them

Companies approved for the same productsMedical Devices

Ranked by how many MFDS product categories overlap. Not a ranking — a pointer to where to look.

JW PHARMACEUTICAL8 shared

Founded in 1945, JW Pharmaceutical holds an original drug pipeline including Rivalo and Hemlibra, plus the IV nutrition product Winuf and OTC brand Hwakol.

MEDIANA Co.,LTD6 shared

Founded in 1995 and listed on KOSDAQ in 2014, Mediana is a hospital medical device maker developing and manufacturing patient monitors and automated external defibrillators under its own brand and via ODM.

MEKICS Co., Ltd5 shared

KOSDAQ-listed critical-care medical device company manufacturing ventilators, the OmniOx respiratory therapy device series, and patient monitors.

MEZOO Co., Ltd.2 shared

KOSDAQ-listed medical device company developing the HiCardi wearable patch-type patient monitor.

SEERS Co., Ltd.2 shared

Founded in 2009, SEERS provides the wearable ECG analysis solution mobiCARE and the inpatient monitoring solution thynC, based on AI vital-sign analytics.

CLASSYS Inc.2 shared

CLASSYS Inc., established in 2015 and listed on KOSDAQ, makes aesthetic medical devices using HIFU, MRF, MNRF, and laser technologies.

SGHEALTHCARE CO.,LTD.1 shared

Founded in 2009 and KOSDAQ-listed in 2024, SGHealthcare manufactures X-ray, CT, and MRI medical imaging diagnostic devices.

Vieworks Co., Ltd.1 shared

Vieworks, founded in 1999 and KOSDAQ-listed in 2009, develops X-ray detectors and industrial camera imaging solutions.

DongBang Medical Co., Ltd.1 shared

KOSDAQ-listed medical device maker producing disposable acupuncture needles, cupping cups, and hyaluronic acid dermal fillers.

BTB Korea Co.,Ltd1 shared

KOSDAQ-listed aesthetic medical device company producing PICO, DUAL HI, and other anti-aging and body-contouring devices.

IMGT Corporation Limited1 shared

IMGT, founded in 2010 and KONEX-listed in 2023, develops the IMD10 focused ultrasound system for anticancer drug delivery.

DAIHAN SCIENTIFIC CO., Ltd1 shared

KOSDAQ-listed lab equipment company manufacturing and distributing ultra-low temperature freezers, centrifuges, and autoclaves.

Sources and updates

Company basics
Korea Exchange · DART
Business content
Compiled from disclosure filings
AI visibility
Measured 2026-08-13

This page is compiled from public sources without the company's involvement. If anything is inaccurate or incomplete, please let us know. Materials provided by the company are labelled as such.

Request a correction or addition