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Medical DevicesKOSDAQ 11548053 approvals

CU MEDICAL SYSTEMS Inc.

Official website

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

As of 2026-10-08, CU MEDICAL SYSTEMS Inc. has 53 Korean MFDS device approvals, 1 PubMed-indexed paper on record (counted by the MAA Company Index from its own matching of public databases).

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Market cap

Business overview

Source: DART corporate disclosure

Founded in 2001 and listed on KOSDAQ in 2011, CU Medical Systems is an emergency medical device company making automated external defibrillators (AEDs). It supplies AEDs to hospitals, fire departments, and public institutions, and offers IoT-enabled products including a Telemetry System, Home AED System, and Institutional AED System along with remote and group management systems. It operates local subsidiaries in Germany and Japan, and according to the 'Defibrillator - Market Share Analysis' report, the global defibrillator market was estimated at USD 13.63 billion in 2024 and is projected to grow at a 7.2% CAGR through 2029 to exceed USD 19.3 billion.

Products & technology

  • Automated external defibrillator (AED)Emergency treatment for arrhythmias such as ventricular fibrillation and ventricular tachycardia
  • Telemetry SystemIoT-based remote monitoring
  • Home AED SystemHome-use AED
  • Institutional AED SystemInstitutional AED
  • IoT-based remote and group management systemAED fleet operation management

Regulatory approvals

data.go.kr

53 Korean MFDS device approvals · 2002–2024

  • MFDSDefibrillator, lowpowered2024-10-18
    Product approval · Class 3제허 24-706 호
  • MFDSProbe, general-purpose, external2024-02-27
    Product approval · Class 1수신 24-340 호
  • MFDSOxygen tube and catheter, single-us2024-02-27
    Product approval · Class 1수신 24-336 호
  • MFDSProbe, general-purpose, external2024-02-14
    Product approval · Class 1수신 24-242 호
  • MFDSProbe, general-purpose, external2024-02-14
    Product approval · Class 1수신 24-241 호
  • MFDSProbe, general-purpose, external2024-01-31
    Product approval · Class 1수신 24-164 호
  • MFDSDefibrillator, lowpowered2023-05-09
    Product approval · Class 3제허 23-569 호
  • MFDSElectrocardiographic Holter analyser2022-05-18
    Product approval · Class 2제인 22-4391 호
  • MFDSDefibrillator, lowpowered2020-12-28
    Product approval · Class 3제허 20-1153 호
  • MFDSElectrode, electrocardiograph, single-useRevoked2020-11-25
    Product approval · Class 1제신 20-1727 호
  • MFDSDefibrillator, lowpowered2020-11-20
    Product approval · Class 3제허 20-984 호
  • MFDSExerciser, orthopaedic, electrically-poweredRevoked2020-11-09
    Product approval · Class 2제인 20-4995 호
Show 41 more
  • MFDSU-healthcare gateway, class 12019-11-06
    Product approval · Class 1제신 19-1438 호
  • MFDSDefibrillator, lowpowered2018-09-18
    Product approval · Class 3제허 18-637 호
  • MFDSGel for medical use, non-sterilized2016-06-13
    Product approval · Class 1수신 16-1558 호
  • MFDSDefibrillator, lowpowered2015-06-04
    Product approval · Class 3제허 15-880 호
  • MFDSHeart rate meter2015-04-02
    Product approval · Class 2제인 15-463 호
  • MFDSElectrocardiographic analyser2015-04-02
    Product approval · Class 2제허 15-468 호
  • MFDSDefibrillator, lowpowered2014-11-07
    Product approval · Class 3제허 14-1952 호
  • MFDSElectrode/lead, stimulator, muscular2014-04-21
    Product approval · Class 2제인 14-909 호
  • MFDSDefibrillator, lowpowered2013-05-23
    Product approval · Class 3제허 13-902 호
  • MFDSCuff, blood pressure2012-09-17
    Product approval · Class 1서울 수신 12-1854 호
  • MFDSCuff, blood pressure2012-09-17
    Product approval · Class 1서울 수신 12-1855 호
  • MFDSCuff, blood pressure2012-09-17
    Product approval · Class 1서울 수신 12-1853 호
  • MFDSDefibrillator, lowpowered2012-08-24
    Product approval · Class 3제허 12-1088 호
  • MFDSHeart rate meter2012-01-16
    Product approval · Class 2제허 12-71 호
  • MFDSLow frequency electric stimulator for medical use, home use2012-01-09
    Product approval · Class 2제허 12-30 호
  • MFDSElectrode/lead, stimulator, muscular2011-12-27
    Product approval · Class 2제인 11-1435 호
  • MFDSElectrode, external2011-09-29
    Product approval · Class 1서울 수신 11-1705 호
  • MFDSElectrode, external2011-06-02
    Product approval · Class 1서울 수신 11-856 호
  • MFDSElectrode, external2011-06-02
    Product approval · Class 1서울 수신 11-857 호
  • MFDSDefibrillator, lowpowered2011-05-03
    Product approval · Class 3제허 11-494 호
  • MFDSElectrode, electrocardiograph, single-use2009-05-04
    Product approval · Class 1서울 수신 09-825 호
  • MFDSDefibrillator, lowpoweredRevoked2009-01-14
    Product approval · Class 3제허 09-20 호
  • MFDSDefibrillator, lowpowered2008-12-24
    Product approval · Class 3제허 08-935 호
  • MFDSElectrode, electrocardiograph, single-useRevoked2008-11-26
    Product approval · Class 1서울 수신 08-2068 호
  • MFDSElectrode, external2008-11-26
    Product approval · Class 1서울 수신 08-2067 호
  • MFDSResuscitator, cardiopulmonary, electrically-poweredRevoked2008-10-04
    Product approval · Class 3수허 08-952 호
  • MFDSDisinfector, ozoneRevoked2008-07-15
    Product approval · Class 2제허 08-462 호
  • MFDSDisinfector, ozoneRevoked2008-07-01
    Product approval · Class 2제허 08-416 호
  • MFDSElectrode, external2008-02-05
    Product approval · Class 1서울 수신 08-195 호
  • MFDSElectrode, external2008-01-04
    Product approval · Class 1서울 수신 08-12 호
  • MFDSDefibrillator, lowpowered2007-12-12
    Product approval · Class 3제허 07-699 호
  • MFDSDefibrillator, lowpoweredRevoked2006-12-27
    Product approval · Class 3제허 06-989 호
  • MFDSDefibrillator, lowpoweredRevoked2006-04-10
    Product approval · Class 3제허 06-268 호
  • MFDSDefibrillator, lowpoweredRevoked2006-03-29
    Product approval · Class 3제허 06-231 호
  • MFDSMonitor, ElectrocardiographRevoked2006-01-23
    Product approval · Class 2제허 06-54 호
  • MFDSElectrode, external2006-01-06
    Product approval · Class 1서울 수신 06-34 호
  • MFDSElectrocardiographic analyserRevoked2004-04-17
    Product approval · Class 2제허 04-380 호
  • MFDSDefibrillator, lowpoweredRevoked2004-03-03
    Product approval · Class 3제허 04-211 호
  • MFDS의료용전극Revoked2003-04-23
    Product approval · Class 1서울 수신 03-1133 호
  • MFDSDefibrillator, lowpoweredRevoked2002-10-17
    Product approval · Class 3제허 02-799 호
  • MFDSDisinfector, ozoneRevoked2002-09-27
    Product approval · Class 2제허 02-767 호

R&D and key agreements

Source: DART corporate disclosure

심전도 분석 알고리즘 · 자동심장충격 판단 · 진행중 · Developing an AI algorithm for ECG analysis used in automated defibrillation

휴대용 현장응급의료장치 · 원격의료지도 · 개발중 · Developing a portable emergency medical device enabling remote medical guidance in the field

자동심폐소생장치 · 심정지 응급처치 · 개발완료 · A fused AED/automated CPR system with efficacy and safety confirmed in animal studies; regulatory approval and commercialization pending

Key disclosures

KRX KIND via OpenDART

Publications

PubMed · affiliation-matched

Patents

KIPRIS · applicant-matched
Show 61 more patents

AI reads

MAA server logs · IP-verified
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  • GoogleGoogleOther11
  • PerplexityPerplexityBot5
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Measured since Aug 27, 2026 · 4 AI engines · last read Oct 7, 2026

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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.,LTD11 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.

BIO PROTECH INC.7 shared

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

SEERS Co., Ltd.5 shared

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

MEKICS Co., Ltd4 shared

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

Autech Corporation4 shared

Founded in 1991 and KOSDAQ-listed in 2003, Autech Corporation manufactures specialty vehicles such as ambulances and refrigerated trucks.

ASTERASYS Co., Ltd.3 shared

Founded in 2015 and listed on KOSDAQ in 2025, ASTERASYS manufactures HIFU and RF-based aesthetic skin devices.

MEZOO Co., Ltd.3 shared

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

Boryung Corporation3 shared

Founded in 1963 and listed in 1988, Boryung is a pharmaceutical and CDMO firm built around its antihypertensive drug Kanarb.

NANOOMTECH Co., Ltd.3 shared

A KONEX-listed medical device maker specializing in automated external defibrillators, including the AI-based ReHeart NT-381.AI model.

CLASSYS Inc.3 shared

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

REMED CO.,LTD.2 shared

KOSDAQ-listed magnetic stimulation medical device company developing TMS-based brain rehabilitation devices and PMS pain management devices.

InBody Co., Ltd.2 shared

Founded 1996, KOSDAQ-listed 2000, InBody makes body composition analyzers via 18 subsidiaries, generating 83% of revenue overseas.

Sources and updates

Counts on this page are not company-reported figures. MAA matched records from DART, the Korean MFDS, the US FDA, ClinicalTrials.gov, PubMed and KIPRIS to this company itself, by business registration number or registered name, never by name similarity. They may differ from figures the company publishes.

Company basics
Korea Exchange · DART
Business content
Compiled from disclosure filings
Approvals & clinical trials
Korean MFDS (data.go.kr) · US FDA openFDA — updated weekly
Key disclosures
KRX KIND via OpenDART exchange filings — updated daily
Global clinical trials
ClinicalTrials.gov (US NIH) — sponsor-matched, updated weekly
Financials
DART corporate disclosure filings — annual
Publications
PubMed (US National Library of Medicine) — affiliation-matched, updated daily
Patents
KIPRIS (Korea Institute of Patent Information) — applicant-matched, updated monthly
AI reads
Our server logs, IP-verified every 6 hours
AI visibility
Measured 2026-10-01

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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