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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.

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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.

Not yet compiled: business overview · R&D. 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.

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.

Alpha AI Co.,Ltd.13 shared

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

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.

Autech Corporation6 shared
Billions Co.,Ltd.6 shared

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

GC Medical Science Corporation6 shared

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

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.

JW PHARMACEUTICAL5 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.

MEKICS Co., Ltd5 shared

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

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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