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Medical DevicesKOSDAQ 100700226 approvals

SEWOONMEDICAL CO,. LTD.

Official website

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

As of 2026-10-10, SEWOONMEDICAL CO,. LTD. has 226 Korean MFDS device approvals 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 1982 and listed on KOSDAQ in 2008, Sewoon Medical is a manufacturer of disposable medical devices including medical aspirators and catheters. Its main products include medical aspirators, catheters and tubes for urinary, gastric, drainage, and drug-infusion use, blood/fluid warmers, vascular access devices, and stents for gastrointestinal disease. It obtained CE certification for European exports in 1997, US FDA approval and Japanese JGMP certification in 2002, and FDA approval for its stent product in 2010, and in 2025 recorded consolidated revenue of KRW 63.7 billion, operating profit of KRW 12.7 billion, and net income of KRW 12.2 billion.

Products & technology

  • Medical aspiratorPost-surgical fluid and plasma drainage
  • Catheters and tubes (urinary, gastric, drainage, drug-infusion)Disposable medical devices for treating various conditions
  • Blood/fluid warmerMaintaining temperature of transfused blood and fluids
  • Vascular access deviceVascular access
  • StentTreatment of gastrointestinal disease

Regulatory approvals

data.go.kr

226 Korean MFDS device approvals · 1972–2026

  • MFDSIntravascular administration set2026-03-17
    Product approval · Class 2제인 26-4248 호
  • MFDSForceps, dressing, manually-operated, single-use2026-02-13
    Product approval · Class 2제인 26-4148 호
  • MFDSGlove, surgical2025-09-09
    Product approval · Class 2수인 25-4523 호
  • MFDSGlove, patient examination2025-01-15
    Product approval · Class 1수신 25-98 호
  • MFDSClip, surgical, external2024-12-26
    Product approval · Class 1제신 24-1644 호
  • MFDSForceps, dressing, manually-operated, reusable2024-11-21
    Product approval · Class 1제허 24-824 호
  • MFDSForceps, dressing, manually-operated, reusable2024-10-10
    Product approval · Class 1제신 24-1226 호
  • MFDSCatheter, urological2024-04-12
    Product approval · Class 2수인 24-192 호
  • MFDSScraper, cytology, single-use2023-08-11
    Product approval · Class 2제인 23-5010 호
  • MFDSProbe, general-purpose, external2023-08-08
    Product approval · Class 1제신 23-1209 호
  • MFDSGlove, patient examination2022-02-04
    Product approval · Class 1수신 22-150 호
  • MFDSCatheterization kit, haemodialysisRevoked2021-07-07
    Product approval · Class 2제허 21-573 호
Show 68 more
  • MFDSIntravascular administration set2021-05-28
    Product approval · Class 2수인 21-4250 호
  • MFDSClip, surgical, externalRevoked2021-05-24
    Product approval · Class 1수신 21-901 호
  • MFDSClip, surgical, external2021-02-26
    Product approval · Class 1수신 21-326 호
  • MFDSClip, surgical, externalRevoked2021-01-29
    Product approval · Class 1제신 21-122 호
  • MFDSProbe, general-purpose, external2020-09-24
    Product approval · Class 1제신 20-1458 호
  • MFDSInfusion filter2020-02-19
    Product approval · Class 2수인 20-4101 호
  • MFDSMask, ventilator2019-08-19
    Product approval · Class 1수신 19-2072 호
  • MFDSCatheter, infusion, drainage2019-07-08
    Product approval · Class 2수인 19-4458 호
  • MFDSCatheter, urological2019-07-05
    Product approval · Class 2수인 19-4455 호
  • MFDSCatheter, urologicalRevoked2019-07-05
    Product approval · Class 2수인 19-4454 호
  • MFDSProbe, general-purpose, internal2019-06-25
    Product approval · Class 2제인 19-4507 호
  • MFDSNeedle, aspiration/injection, single-use2019-02-22
    Product approval · Class 2수인 19-4121 호
  • MFDSCatheter, infusion, drainage2019-02-01
    Product approval · Class 2제인 19-4082 호
  • MFDSMask, ventilatorRevoked2019-01-03
    Product approval · Class 1수신 19-29 호
  • MFDSOxygen tube and catheter, single-us2018-12-07
    Product approval · Class 1수신 18-2692 호
  • MFDSDrape, surgical, general purpose, non-contact type, single-use2018-11-28
    Product approval · Class 2제인 18-4975 호
  • MFDSGlove, surgicalRevoked2018-09-27
    Product approval · Class 2수인 18-4651 호
  • MFDSCatheter, urological2018-08-06
    Product approval · Class 2수인 18-4542 호
  • MFDSDrape, surgical, general purpose, non-contact type, reusableRevoked2018-05-10
    Product approval · Class 1제신 18-570 호
  • MFDSTracheal tube stylet, reusable2018-02-02
    Product approval · Class 1제신 18-131 호
  • MFDSIrrigation syringe2017-10-25
    Product approval · Class 1수신 17-3121 호
  • MFDSGlove, patient examinationRevoked2017-10-25
    Product approval · Class 1수신 17-3119 호
  • MFDSDisposable sucker2017-10-25
    Product approval · Class 1수신 17-3114 호
  • MFDSGlove, patient examinationRevoked2017-10-24
    Product approval · Class 1수신 17-3104 호
  • MFDSCatheter, evacuator2017-03-27
    Product approval · Class 1수신 17-910 호
  • MFDSInjector, medication/vaccine, syringe2017-03-24
    Product approval · Class 2수인 17-4152 호
  • MFDSInjector, medication/vaccine, syringe2017-03-24
    Product approval · Class 2수인 17-4150 호
  • MFDSCatheter, evacuator2017-01-03
    Product approval · Class 1수신 17-35 호
  • MFDSDisposable sucker2016-12-02
    Product approval · Class 1제신 16-1441 호
  • MFDSGlove, surgicalRevoked2016-11-01
    Product approval · Class 2수인 16-4634 호
  • MFDSForceps, single-useRevoked2016-11-01
    Product approval · Class 2수인 16-4633 호
  • MFDSCatheter, infusion, drainage2016-10-31
    Product approval · Class 2제인 16-4828 호
  • MFDSCatheter, infusion, drainageRevoked2016-10-31
    Product approval · Class 2제인 16-4831 호
  • MFDSUmbilical cord clip2016-10-31
    Product approval · Class 2제인 16-4827 호
  • MFDSCatheter, infusion, drainageRevoked2016-10-31
    Product approval · Class 2수인 16-4631 호
  • MFDSCatheter, infusion, drainageRevoked2016-10-31
    Product approval · Class 2수인 16-4630 호
  • MFDSCatheter, evacuator2016-10-27
    Product approval · Class 1수신 16-2754 호
  • MFDSGlove, patient examinationRevoked2016-06-03
    Product approval · Class 1수신 16-1489 호
  • MFDSIntravascular catheter, short-term2016-05-17
    Product approval · Class 2수인 16-4285 호
  • MFDSForceps, dressing, manually-operated, single-use2016-03-24
    Product approval · Class 2제허 16-215 호
  • MFDSCatheter, urological2015-10-16
    Product approval · Class 2수인 15-4122 호
  • MFDSDisposable suckerRevoked2015-08-10
    Product approval · Class 1제신 15-30 호
  • MFDSBag, ostomy2015-07-13
    Product approval · Class 1대전 수신 15-54 호
  • MFDSSpeculumsRevoked2015-06-12
    Product approval · Class 1대전 수신 15-44 호
  • MFDSDisposable suckerRevoked2015-05-13
    Product approval · Class 1대전 제신 15-44 호
  • MFDSDisposable sucker2015-05-13
    Product approval · Class 1대전 제신 15-43 호
  • MFDSIntravascular administration set2014-11-12
    Product approval · Class 2수인 14-3101 호
  • MFDSProbe, general-purpose, internal2014-08-18
    Product approval · Class 2제인 14-1485 호
  • MFDSBreast prosthesis, internal, gel-filledRevoked2014-07-04
    Product approval · Class 4제허 14-1275 호
  • MFDSWarmer, blood/solution2014-01-20
    Product approval · Class 2제인 14-185 호
  • MFDSDisposable suckerRevoked2013-12-04
    Product approval · Class 1대전 제신 13-101 호
  • MFDSCatheter, epiduralRevoked2013-10-11
    Product approval · Class 3제허 13-1726 호
  • MFDSWarmer, blood/solutionRevoked2013-09-10
    Product approval · Class 2제허 13-1563 호
  • MFDSCatheter, cerebrospinal, single-useRevoked2013-04-11
    Product approval · Class 4제허 13-685 호
  • MFDSIntravascular administration setRevoked2012-03-28
    Product approval · Class 2수허 12-467 호
  • MFDSCatheterization kit, haemodialysisRevoked2012-03-13
    Product approval · Class 2수허 12-391 호
  • MFDSDressing, occlusive, hydrogelRevoked2012-02-22
    Product approval · Class 2제허 12-209 호
  • MFDSIntravascular catheter, short-term2012-02-06
    Product approval · Class 2제인 12-155 호
  • MFDSContraceptive, fallopian tube clip/band/insertRevoked2011-12-27
    Product approval · Class 4제허 11-1438 호
  • MFDSCatheter, epidural2011-12-12
    Product approval · Class 3제허 11-1354 호
  • MFDSIntravascular administration setRevoked2011-08-30
    Product approval · Class 2제허 11-947 호
  • MFDSSuction system, low pressureRevoked2011-07-26
    Product approval · Class 2수허 11-873 호
  • MFDSSuction system, low pressure2011-07-11
    Product approval · Class 2제인 11-744 호
  • MFDSSuction system, low pressure2011-04-14
    Product approval · Class 2제인 11-420 호
  • MFDSElectrosurgical system electrode, foot-controlled, single-useRevoked2011-03-07
    Product approval · Class 2수인 11-287 호
  • MFDSForceps, reusableRevoked2011-01-27
    Product approval · Class 1대전 제신 11-7 호
  • MFDSIrrigation unit, general purpose, manually-operated2010-10-29
    Product approval · Class 1대전 제신 10-103 호
  • MFDSIrrigation unit, general purpose, manually-operated2010-10-01
    Product approval · Class 1대전 제신 10-98 호

Showing the 80 most recent of 226 records.

Patents

KIPRIS · applicant-matched
Show 15 more patents

AI reads

MAA server logs · IP-verified
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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.

Alpha AI Co.,Ltd.14 shared

Alpha AI, founded in 1995 and KOSDAQ-listed in 2000, manufactures biocompatible metal implants and surgical instruments.

MITECH CO.,LTD.14 shared

MITECH CO.,LTD., founded in 1991 and listed on KOSDAQ in 2018, makes non-vascular stents and distributes Fujifilm endoscopy equipment.

SHINHUNG CO.,LTD13 shared

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

DONG-A ST CO.,LTD11 shared

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

MEDIANA Co.,LTD8 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.

SEJONG MEDICAL Co.Ltd.,7 shared

Founded in 2010 and KOSDAQ-listed in 2018, Sejong Medical manufactures laparoscopic surgical instruments.

DongBang Medical Co., Ltd.7 shared

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

HLB Life Science CO.,LTD.6 shared

Founded in 1998 and listed on KOSDAQ in 2008, HLB Life Science operates four business divisions: medicare, bio-development, medical devices, and energy.

Autech Corporation6 shared

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

GC Medical Science Corporation6 shared

GC Medical Science Corporation, KOSDAQ-listed since 2014, operates diagnostic reagent, blood glucose, and hemodialysis solution businesses.

Billions Co.,Ltd.6 shared

Founded in 1973, KOSDAQ-listed in 2001, Billions makes medical rubber products like condoms and runs an entertainment business.

Boryung Corporation5 shared

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

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

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