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Medical DevicesKOSDAQ 041920MAA Member185 approvals

MEDIANA Co.,LTD

Official website

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.

As of 2026-10-10, MEDIANA Co.,LTD has 179 Korean MFDS device approvals, 6 US FDA clearances/approvals, 6 PubMed-indexed papers 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

Mediana was founded in 1995 and listed on the KOSDAQ market in 2014 as a hospital medical device specialist. The company develops, manufactures, and sells patient monitors and automated external defibrillators (AEDs) under its own brand and through ODM (Original Development Manufacturing), with export and overseas distribution agreements with Medtronic (US) and Siemens (Germany). Based on sales, its global patient monitor market share is estimated at about 0.8% and its domestic market share at about 20%, and it is also expanding into AI/software-linked businesses including wearable ECG patches and an integrated monitoring solution.

Products & technology

  • Patient MonitorReal-time measurement and monitoring of vital signs (ECG, SpO2, blood pressure, temperature) for use in ICU, ER, and operating room settings
  • Automated External Defibrillator (AED)Emergency treatment for cardiac arrest patients, used in hospitals and public/industrial settings
  • Wearable ECG PatchNew product line under active expansion

Regulatory approvals

data.go.kr · openFDA

179 Korean MFDS device approvals · 1996–2026 / 6 US FDA 510(k) · 2011–2020

  • MFDSLight, transilluminator2026-07-20
    Product approval · Class 1수신 26-1592 호
  • MFDSProduct name not recorded2026-05-14
    Product approval · Class 1신 26-53 호
  • MFDSElectrocardiographic Holter analyser2026-04-21
    Product approval · Class 2제인 26-4347 호
  • MFDSCatheter guidewire, vascular2026-03-24
    Product approval · Class 2제인 26-4264 호
  • MFDSResuscitator, cardiopulmonary, electrically-powered2025-07-25
    Product approval · Class 3제허 25-507 호
  • MFDSClip, surgical, external2024-11-19
    Product approval · Class 1제신 24-1432 호
  • MFDSClip, surgical, external2024-11-14
    Product approval · Class 1제신 24-1416 호
  • MFDSPatient monitor2024-09-19
    Product approval · Class 2제인 24-860 호
  • MFDSPulse oximeter, line-poweredRevoked2023-11-22
    Product approval · Class 2수허 23-375 호
  • MFDSSphygmomanometer, electronic, automatic-inflation, non-portable2023-02-08
    Product approval · Class 2수허 23-29 호
  • MFDSThermometer, electronic, infrared, ear2022-10-12
    Product approval · Class 2수인 22-4481 호
  • MFDSDefibrillator, lowpowered2022-03-10
    Product approval · Class 3제허 22-158 호
Show 68 more
  • MFDSBody fat/lean ratio analyser, impedance2021-11-24
    Product approval · Class 2제인 21-4982 호
  • MFDSNerve function monitor2021-11-12
    Product approval · Class 2수인 21-4530 호
  • MFDSPatient monitor2020-12-29
    Product approval · Class 2수인 20-4867 호
  • MFDSPatient monitor2020-11-26
    Product approval · Class 2제인 20-5038 호
  • MFDSPatient monitor2020-11-10
    Product approval · Class 2제인 20-5001 호
  • MFDSPatient monitor2020-10-19
    Product approval · Class 2제인 20-4943 호
  • FDAV20, V20a, AVSM3 SNF2020-10-09
    510(k) · TraditionalCardiovascularK200434
  • MFDSOxygen tube and catheter, single-us2020-06-12
    Product approval · Class 1수신 20-1397 호
  • MFDSPatient monitor2020-05-11
    Product approval · Class 2수허 20-100 호
  • MFDSCuff, blood pressure2020-04-14
    Product approval · Class 1수신 20-913 호
  • MFDSElectrode, external2020-04-08
    Product approval · Class 1수신 20-868 호
  • MFDSCuff, blood pressure2020-04-06
    Product approval · Class 1수신 20-844 호
  • MFDSCuff, blood pressure2020-03-20
    Product approval · Class 1수신 20-719 호
  • MFDSCuff, blood pressure2020-03-19
    Product approval · Class 1수신 20-713 호
  • MFDSPatient monitoring system, transportable2020-03-10
    Product approval · Class 2제인 20-4185 호
  • MFDSClip, surgical, externalRevoked2020-02-14
    Product approval · Class 1수신 20-382 호
  • MFDSDefibrillator, lowpowered2020-02-11
    Product approval · Class 3제허 20-107 호
  • MFDSDefibrillator, lowpowered2020-01-21
    Product approval · Class 3제허 20-49 호
  • MFDSResuscitator, cardiopulmonary, electrically-powered2019-09-26
    Product approval · Class 3제허 19-611 호
  • MFDSBody fat/lean ratio analyser, impedance2019-09-10
    Product approval · Class 2제인 19-4775 호
  • MFDSDefibrillator, lowpowered2019-08-08
    Product approval · Class 3제허 19-527 호
  • MFDSPatient monitoring system module2019-07-11
    Product approval · Class 2제인 19-4587 호
  • MFDSElectrocardiograph electrode, neonatal2019-06-24
    Product approval · Class 1수신 19-1504 호
  • MFDSElectrode, electrocardiograph, single-use2019-06-24
    Product approval · Class 1수신 19-1503 호
  • MFDSLight, transilluminator2019-05-28
    Product approval · Class 1수신 19-1267 호
  • MFDSMarker, surgical, external2019-05-03
    Product approval · Class 1수신 19-1007 호
  • MFDSElectrode, external2019-04-30
    Product approval · Class 1수신 19-992 호
  • MFDSPatient monitoring system, transportable2019-03-04
    Product approval · Class 2제인 19-4142 호
  • MFDSPatient monitor2019-01-17
    Product approval · Class 2제인 19-4036 호
  • MFDSPatient monitor2018-10-30
    Product approval · Class 2제허 18-711 호
  • MFDSBody fat/lean ratio analyser, impedance2018-08-03
    Product approval · Class 2제인 18-4627 호
  • MFDSElectrode, electrocardiograph, single-use2018-05-14
    Product approval · Class 1수신 18-981 호
  • MFDSCatheter introducer2018-04-20
    Product approval · Class 2제인 18-4306 호
  • MFDSOxygen tube and catheter, single-us2018-04-03
    Product approval · Class 1수신 18-719 호
  • MFDSIntravascular catheter, short-term2018-03-21
    Product approval · Class 2제인 18-4211 호
  • MFDSCatheter introducer2018-02-22
    Product approval · Class 2제인 18-4135 호
  • MFDSClip, surgical, external2018-01-22
    Product approval · Class 1수신 18-160 호
  • MFDSVentilator, continuous, facility use2017-12-22
    Product approval · Class 3수허 17-571 호
  • FDAV102017-12-15
    510(k) · TraditionalCardiovascularK170497
  • MFDSElectrode, external2017-11-01
    Product approval · Class 1수신 17-3186 호
  • MFDSOxygen tube and catheter, single-us2017-08-29
    Product approval · Class 1수신 17-2641 호
  • MFDSPulse oximeter, line-poweredRevoked2017-03-22
    Product approval · Class 2수인 17-4148 호
  • FDADT-1002017-02-24
    510(k) · TraditionalGeneral HospitalK160358
  • FDAV102016-08-25
    510(k) · TraditionalCardiovascularK152659
  • MFDSPatient monitor2016-04-25
    Product approval · Class 2제인 16-4349 호
  • MFDSLight, transilluminator2016-02-23
    Product approval · Class 1수신 16-473 호
  • MFDSOxygen tube and catheter, single-usRevoked2015-11-25
    Product approval · Class 1수신 15-1082 호
  • MFDSPatient monitor, centralRevoked2015-10-21
    Product approval · Class 2제인 15-4212 호
  • MFDSElectrocardiographic analyser2015-10-14
    Product approval · Class 2제인 15-4194 호
  • MFDSPatient monitor, central2015-08-03
    Product approval · Class 2제인 15-1258 호
  • MFDSPatient monitor, centralRevoked2015-08-03
    Product approval · Class 2제인 15-1259 호
  • MFDSPatient monitorRevoked2015-05-12
    Product approval · Class 2수허 15-926 호
  • MFDSPatient monitorRevoked2015-05-08
    Product approval · Class 2수허 15-915 호
  • MFDSPatient monitorRevoked2015-04-24
    Product approval · Class 2수인 15-849 호
  • MFDSElectrode, electrocardiograph, vacuum2015-01-20
    Product approval · Class 1서울 수신 15-151 호
  • MFDSCuff, blood pressure2014-12-24
    Product approval · Class 1서울 수신 14-3168 호
  • MFDSCuff, blood pressure2014-12-24
    Product approval · Class 1서울 수신 14-3166 호
  • MFDSPatient monitor, central2014-11-24
    Product approval · Class 2수인 14-3333 호
  • MFDSPulse oximeter, line-powered2014-10-22
    Product approval · Class 2제인 14-1875 호
  • MFDSCuff, blood pressure2014-10-15
    Product approval · Class 1서울 수신 14-2578 호
  • MFDSDefibrillator, lowpowered2014-09-02
    Product approval · Class 3제허 14-1593 호
  • MFDSElectrocardiographic Holter analyserRevoked2014-06-19
    Product approval · Class 2수인 14-2116 호
  • MFDSElectrode, external2014-05-21
    Product approval · Class 1서울 수신 14-1518 호
  • MFDSElectrode, external2014-05-21
    Product approval · Class 1서울 수신 14-1519 호
  • MFDSOxygen tube and catheter, single-usRevoked2014-04-21
    Product approval · Class 1서울 수신 14-1265 호
  • MFDSElectrocardiographic analyserRevoked2014-04-04
    Product approval · Class 2수인 14-1608 호
  • MFDSElectrocardiographic analyserRevoked2014-03-28
    Product approval · Class 2수인 14-1521 호
  • MFDSPulse oximeter, line-powered2014-03-28
    Product approval · Class 2제인 14-749 호

Showing the 80 most recent of 185 records.

Publications

PubMed · affiliation-matched

Patents

KIPRIS · applicant-matched
Show 60 more patents

AI reads

MAA server logs · IP-verified
116
Times AI engines pulled MEDIANA Co.,LTD's records

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Last 7 days
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  • OpenAIOAI-SearchBot91
  • PerplexityPerplexityBot9
  • GoogleGoogleOther8
  • AnthropicClaudeBot2
  • MicrosoftBingbot1

Measured since Aug 25, 2026 · 5 AI engines · last read Oct 9, 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.

MEKICS Co., Ltd14 shared

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

CU MEDICAL SYSTEMS Inc.11 shared

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

Autech Corporation9 shared

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

SEWOONMEDICAL CO,. LTD.8 shared

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

SEERS Co., Ltd.8 shared

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

DONG-A ST CO.,LTD7 shared

Dong-A ST, spun off from Dong-A Socio Holdings in 2013 and KOSPI-listed, makes prescription drugs like Growtropin, Stillen, and Bacchus.

Bistos Co., Ltd.6 shared

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

SELVAS Healthcare, Inc.6 shared

SELVAS Healthcare operates the ACCUNIQ medical diagnostic device brand and the HIMS assistive technology device brand.

CLASSYS Inc.6 shared

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

BIO PROTECH INC.6 shared

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

SHINHUNG CO.,LTD5 shared

Founded in 1964 and KOSPI-listed in 1991, Shinhung manufactures and distributes dental equipment and materials.

InBody Co., Ltd.5 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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