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Medical DevicesKOSDAQ 058110100 approvals

MEKICS Co., Ltd

Official website

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

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Business overview

Source: DART corporate disclosure

Founded in 1998 and listed on KOSDAQ in 2015, MEKICS is a medical device manufacturer specializing in ventilators, respiratory therapy devices, and patient monitors. It offers the OmniOx respiratory therapy device series (hospital models 750A/750B/750S, home models 751B/751S, and the U.S.-focused 750U), the MP1300 patient monitor, the MV2000 ICU ventilator, the M3/M4 CPAP devices, and the Meerkat medical cloud platform. In 2025, standalone revenue recovered to KRW 11.3 billion from KRW 10.4 billion the prior year, operating loss narrowed from KRW 9.4 billion to about KRW 1.3 billion and net loss from KRW 10.3 billion to about KRW 1.8 billion, disposable unit sales rose from 10,000 in 2024 to over 30,000 in 2025 (accounting for 18% of total revenue and 30% of domestic revenue), and the 750U model received U.S. FDA 510(k) clearance in May 2025.

Products & technology

  • OmniOx 750A/750B/750SHospital respiratory therapy device
  • OmniOx 751B/751SHome respiratory therapy device
  • OmniOx 750URespiratory therapy device for the U.S. market
  • MP1300Patient monitor with ECG, SpO2, NBP, IBP, and ICO modules
  • MV2000ICU ventilator
  • HFT500/700/750/751/750SHigh-flow respiratory therapy device
  • MTV1000Portable ventilator
  • M3/M4Continuous positive airway pressure (CPAP) device
  • MC3/MC200Medical compressor
  • MP601/MP602Central patient monitoring system
  • MP603U-healthcare diagnostic support software
  • MK102Neuromonitoring device
  • LF100Oxygen concentrator
  • MeerkatMedical cloud platform including an AI-based central monitoring system

Regulatory approvals

data.go.kr · openFDA

99 Korean MFDS device approvals · 1999–2026 / 1 US FDA 510(k) · 2025

  • MFDSOxygen tube and catheter, single-us2026-04-13
    Product approval · Class 1제신 26-434 호
  • MFDSNebulizing system, non-heated2025-11-26
    Product approval · Class 2제인 25-5105 호
  • MFDSPatient monitoring software2025-06-02
    Product approval · Class 2제인 25-4478 호
  • MFDSU-healthcare, decision support software2025-05-30
    Product approval · Class 3제허 25-366 호
  • MFDSPatient monitor2025-05-19
    Product approval · Class 2제인 25-4427 호
  • MFDSPatient monitor2025-05-19
    Product approval · Class 2제인 25-4426 호
  • FDAHFT750U2025-05-15
    510(k) · TraditionalAnesthesiologyK242931
  • MFDSBandage, compression2025-03-04
    Product approval · Class 1제신 25-242 호
  • MFDSProbe, general-purpose, external2025-02-12
    Product approval · Class 1수신 25-277 호
  • MFDSProbe, general-purpose, external2025-02-11
    Product approval · Class 1수신 25-275 호
  • MFDSProbe, general-purpose, external2025-02-10
    Product approval · Class 1수신 25-253 호
  • MFDSCuff, blood pressure2025-02-05
    Product approval · Class 1수신 25-230 호
Show 68 more
  • MFDSCuff, blood pressure2025-02-05
    Product approval · Class 1수신 25-228 호
  • MFDSElectrode, electrocardiograph, single-use2025-02-05
    Product approval · Class 1수신 25-227 호
  • MFDSVentilator, continuous, home-use2025-01-06
    Product approval · Class 3제허 25-13 호
  • MFDSVentilator, continuous, facility use2024-10-23
    Product approval · Class 3제허 24-722 호
  • MFDSProbe, general-purpose, external2024-09-04
    Product approval · Class 1수신 24-1654 호
  • MFDSOxygen tube and catheter, single-us2024-07-19
    Product approval · Class 1제신 24-916 호
  • MFDSOxygen tube and catheter, single-us2024-05-16
    Product approval · Class 1수신 24-878 호
  • MFDSOxygen tube and catheter, single-us2023-11-27
    Product approval · Class 1제신 23-1695 호
  • MFDSOxygen tube and catheter, single-us2023-10-12
    Product approval · Class 1수신 23-2439 호
  • MFDSOxygen tube and catheter, single-us2023-08-04
    Product approval · Class 1제신 23-1200 호
  • MFDSVentilator, continuous, facility use2023-05-30
    Product approval · Class 3제허 23-620 호
  • MFDSHumidifier, heat/moisture exchange2023-04-28
    Product approval · Class 2제인 23-4678 호
  • MFDSOxygen therapy delivery system2023-03-29
    Product approval · Class 2제인 23-4595 호
  • MFDSOxygen tube and catheter, single-us2022-10-20
    Product approval · Class 1제신 22-1444 호
  • MFDSPatient monitor2022-10-07
    Product approval · Class 2제인 22-4759 호
  • MFDSVentilator, continuous, home-use2022-08-10
    Product approval · Class 3제허 22-548 호
  • MFDSPatient monitor, central2022-05-26
    Product approval · Class 2제인 22-4412 호
  • MFDSVentilator, continuous, facility use2022-04-27
    Product approval · Class 3제허 22-265 호
  • MFDSOxygen tube and catheter, single-us2022-03-29
    Product approval · Class 1제신 22-404 호
  • MFDSMask, ventilator2022-01-03
    Product approval · Class 1수신 22-5 호
  • MFDSMask, ventilator2022-01-03
    Product approval · Class 1수신 22-4 호
  • MFDSGas tube and catheter2021-01-21
    Product approval · Class 1수신 21-103 호
  • MFDSOxygen tube and catheter, single-us2021-01-20
    Product approval · Class 1수신 21-95 호
  • MFDSOxygen tube and catheter, single-us2021-01-19
    Product approval · Class 1수신 21-82 호
  • MFDSOxygen tube and catheter, single-us2020-04-27
    Product approval · Class 1제신 20-577 호
  • MFDSOxygen tube and catheter, single-us2020-04-07
    Product approval · Class 1제신 20-490 호
  • MFDSPositive airway pressure unit2020-03-13
    Product approval · Class 2제인 20-178 호
  • MFDSElectromyograph2020-01-08
    Product approval · Class 2제인 20-4018 호
  • MFDSOxygen tube and catheter, single-us2019-12-06
    Product approval · Class 1수신 19-3177 호
  • MFDSPositive airway pressure unit2019-10-11
    Product approval · Class 2제인 19-643 호
  • MFDSElectromyograph2019-08-05
    Product approval · Class 2제인 19-4659 호
  • MFDSPatient monitor, central2017-10-26
    Product approval · Class 2제인 17-4812 호
  • MFDSMask, ventilator2016-12-21
    Product approval · Class 1수신 16-3339 호
  • MFDSMask, ventilator2016-12-12
    Product approval · Class 1수신 16-3196 호
  • MFDSMask, ventilator2016-12-12
    Product approval · Class 1수신 16-3195 호
  • MFDSMask, ventilator2016-12-12
    Product approval · Class 1수신 16-3194 호
  • MFDSMask, ventilator2016-11-24
    Product approval · Class 1수신 16-3013 호
  • MFDSMask, ventilator2016-11-23
    Product approval · Class 1수신 16-3002 호
  • MFDSOxygen tube and catheter, single-us2016-11-23
    Product approval · Class 1제신 16-1400 호
  • MFDSOxygen tube and catheter, single-us2016-07-28
    Product approval · Class 1제신 16-928 호
  • MFDSOxygen tube and catheter, single-us2016-07-27
    Product approval · Class 1제신 16-926 호
  • MFDSOxygen tube and catheter, single-us2016-03-28
    Product approval · Class 1수신 16-825 호
  • MFDSOxygen tube and catheter, single-us2016-03-02
    Product approval · Class 1수신 16-544 호
  • MFDSOxygen tube and catheter, single-us2016-01-13
    Product approval · Class 1수신 16-103 호
  • MFDSOxygen tube and catheter, single-us2015-11-04
    Product approval · Class 1제신 15-347 호
  • MFDSHumidifier, heat/moisture exchangeRevoked2015-08-12
    Product approval · Class 2수인 15-4018 호
  • MFDSOxygen tube and catheter, single-us2015-05-11
    Product approval · Class 1경인 수신 15-231 호
  • MFDSHumidifier, heat/moisture exchangeRevoked2015-04-09
    Product approval · Class 2수인 15-766 호
  • MFDSOxygen tube and catheter, single-us2015-02-25
    Product approval · Class 1경인 수신 15-84 호
  • MFDSMask, ventilator2015-02-06
    Product approval · Class 1경인 수신 15-62 호
  • MFDSOxygen tube and catheter, single-usRevoked2014-11-19
    Product approval · Class 1경인 수신 14-662 호
  • MFDSOxygen tube and catheter, single-us2014-11-11
    Product approval · Class 1경인 수신 14-493 호
  • MFDSPositive airway pressure unit2014-10-22
    Product approval · Class 2제인 14-1868 호
  • MFDSOxygen tube and catheter, single-us2013-06-07
    Product approval · Class 1서울 제신 13-177 호
  • MFDSPulse oximeter, line-poweredRevoked2013-01-07
    Product approval · Class 2제허 13-149 호
  • MFDSOxygen tube and catheter, single-us2012-12-04
    Product approval · Class 1서울 제신 12-283 호
  • MFDSPositive airway pressure unit2012-11-27
    Product approval · Class 2제인 12-1508 호
  • MFDSPositive airway pressure unitRevoked2012-10-24
    Product approval · Class 3제허 12-1352 호
  • MFDSHumidifier, heat/moisture exchangeRevoked2012-07-02
    Product approval · Class 2수허 12-997 호
  • MFDSVentilator, continuous, facility use2012-02-15
    Product approval · Class 3제허 12-188 호
  • MFDSPatient monitor2011-07-14
    Product approval · Class 2제인 11-770 호
  • MFDSPatient monitor2011-07-07
    Product approval · Class 2제인 11-730 호
  • MFDSHumidifier, heat/moisture exchangeRevoked2011-06-10
    Product approval · Class 2수허 11-640 호
  • MFDSOxygen tube and catheter, single-usRevoked2011-01-05
    Product approval · Class 1서울 수신 11-21 호
  • MFDSPatient monitor2010-04-12
    Product approval · Class 2제인 10-318 호
  • MFDSPatient monitor2009-07-13
    Product approval · Class 2제인 09-516 호
  • MFDSVentilator, continuous, facility useRevoked2008-11-24
    Product approval · Class 3제허 08-848 호
  • MFDS의료용온습도조절기Revoked2008-10-01
    Product approval · Class 2수허 08-936 호

Showing the 80 most recent of 100 records.

R&D and key agreements

Source: DART corporate disclosure

환자감시장치 모듈 개발(ECG/SpO2/NBP/IBP/ICO) · 상용화(MP1300 등) · In-house development of ECG, SpO2, NBP, IBP, and cardiac output measurement modules

고유량 호흡치료기 개발 · 상용화(HFT 시리즈) · Development of Jet Flow-based high-flow respiratory therapy device and dedicated nasal cannula

양압지속유지기(CPAP) 개발 · 수면무호흡/저호흡 · 상용화(M3/M4) · Sleep apnea/hypopnea diagnostic algorithm and CPAP Cloud patient support system

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.

MEDIANA Co.,LTD14 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.

SEERS Co., Ltd.6 shared

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

Bistos Co., Ltd.5 shared

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

SEWOONMEDICAL CO,. LTD.5 shared

Founded in 1982 and KOSDAQ-listed in 2008, Sewoon Medical manufactures medical aspirators and catheters/tubes.

Autech Corporation4 shared
CU MEDICAL SYSTEMS Inc.4 shared

Founded in 2001 and KOSDAQ-listed in 2011, CU Medical Systems makes AEDs and other emergency medical devices.

MEZOO Co., Ltd.4 shared

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

BIO PROTECH INC.2 shared

Manufactures biosensors for electronic medical device consumables, including ECG measurement electrodes.

Boditech Med Inc.2 shared

KOSDAQ-listed point-of-care immunodiagnostics company supplying diagnostic cartridges and the ichroma/AFIAS instrument series.

Hancom Lifecare Inc.2 shared

Hancom Lifecare, founded in 1971 and KOSPI-listed in 2021, manufactures personal protective equipment (PPE).

JW PHARMACEUTICAL2 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.

Yuyu Pharma, Inc.2 shared

Founded in 1941 and listed on the KOSPI in 1975, Yuyu Pharma is a pharmaceutical company with a co-promotion agreement with Dong-A ST for Tanamin.

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.

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