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Medical DevicesKOSDAQ 179290243 approvals

MITECH CO.,LTD.

Official website

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

As of 2026-10-10, MITECH CO.,LTD. has 232 Korean MFDS device approvals, 11 US FDA clearances/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

MITECH CO.,LTD. was founded in 1991 and listed on KOSDAQ in 2018. It produces non-vascular stents including HANAROSTENT and CHOOSTENT, and since June 2020 has imported and distributed Fujifilm endoscopy equipment (ELUXEO) in Korea. As of December 31, 2025, stents made up 81.58% of revenue and endoscopy products 9.43%, with CE MDR certification obtained in the EU since 2023.

Products & technology

  • Stents (HANAROSTENT, CHOOSTENT, etc.)Implantable medical device inserted into occluded vessels or organs to maintain patency, used to open vessels or digestive organs blocked by tumors etc.
  • Fujifilm gastrointestinal endoscope (ELUXEO)Medical device for direct visualization of internal organs or body cavities (imported and distributed since June 2020)

Regulatory approvals

data.go.kr · openFDA

232 Korean MFDS device approvals · 1994–2026 / 11 US FDA 510(k) · 2016–2025

  • MFDSScraper, cytology, single-use2026-09-10
    Product approval · Class 2수인 26-4650 호
  • MFDSBronchial stent2026-07-07
    Product approval · Class 3제허 26-524 호
  • MFDSEndotherapy needle, general-purpose, single-use2026-06-24
    Product approval · Class 2수인 26-4445 호
  • MFDSSmall inestinoscopeA, fibreoptic, video2026-06-15
    Product approval · Class 2수인 26-4408 호
  • MFDSEndotherapy device, general-purpose, single-use2026-05-29
    Product approval · Class 2수인 26-4374 호
  • MFDSCatheter guidewire, enteral2026-04-27
    Product approval · Class 2수인 26-4291 호
  • MFDSColonoscope, video2026-04-14
    Product approval · Class 2수인 26-4252 호
  • MFDSGastroscope, video2026-01-26
    Product approval · Class 2수인 26-4089 호
  • MFDSClip, implantable, haemostatic2026-01-07
    Product approval · Class 2수인 26-4024 호
  • MFDSElectrosurgical system electrode, foot-controlled, single-use2026-01-05
    Product approval · Class 2수인 26-4008 호
  • MFDSSmall inestinoscopeA, fibreoptic, videoRevoked2025-12-23
    Product approval · Class 2수인 25-4745 호
  • FDAHANAROSTENT Esophagus Upper (CCC)2025-10-30
    510(k) · SpecialGeneral, Plastic SurgeryK253327
Show 68 more
  • MFDSGastroscope, video2025-10-16
    Product approval · Class 2수인 25-4595 호
  • MFDSAdaptor, endoscope element2025-10-16
    Product approval · Class 1수신 25-2220 호
  • MFDSLight source, endoscope2025-09-05
    Product approval · Class 2수인 25-4519 호
  • MFDSAdaptor, endoscope element2025-08-27
    Product approval · Class 1수신 25-1860 호
  • MFDSAdaptor, endoscope element2025-08-12
    Product approval · Class 1수신 25-1754 호
  • MFDSBronchoscope, flexible, video2025-08-07
    Product approval · Class 2수인 25-4448 호
  • MFDSIrrigation unit, general purpose, electrically-powered2025-05-29
    Product approval · Class 2수인 25-4310 호
  • MFDSPneumoperitoneum apparatus2025-05-26
    Product approval · Class 2수인 25-4299 호
  • MFDSCleansing tube and catheter2025-05-21
    Product approval · Class 1수신 25-1018 호
  • MFDSCleansing tube and catheter2025-05-21
    Product approval · Class 1수신 25-1017 호
  • MFDSUltrasonic endoscope2024-08-20
    Product approval · Class 2수인 24-414 호
  • MFDSBiliary stent2024-04-29
    Product approval · Class 3제허 24-298 호
  • MFDSEndotherapy device, general-purpose, single-use2024-02-27
    Product approval · Class 2수인 24-88 호
  • MFDSBiliary stent2023-10-19
    Product approval · Class 3제허 23-994 호
  • MFDSAdaptor, endoscope element2023-04-24
    Product approval · Class 1수신 23-1087 호
  • MFDSAdaptor, endoscope element2023-04-24
    Product approval · Class 1수신 23-1079 호
  • MFDSAdaptor, endoscope element2023-04-24
    Product approval · Class 1수신 23-1077 호
  • MFDSAdaptor, endoscope element2023-04-24
    Product approval · Class 1수신 23-1075 호
  • MFDSAdaptor, endoscope element2023-04-24
    Product approval · Class 1수신 23-1068 호
  • MFDSAdaptor, endoscope element2023-04-21
    Product approval · Class 1수신 23-1059 호
  • MFDSAdaptor, endoscope element2023-04-19
    Product approval · Class 1수신 23-1039 호
  • MFDSOesophageal stentRevoked2023-01-25
    Product approval · Class 3제허 23-59 호
  • MFDSBiliary stent2022-10-11
    Product approval · Class 3제허 22-681 호
  • MFDSUreteral stent2022-09-26
    Product approval · Class 3제허 22-644 호
  • MFDSBiliary stent2022-07-04
    Product approval · Class 3제허 22-425 호
  • MFDSGastroscope, video2022-05-04
    Product approval · Class 2수인 22-4235 호
  • MFDSBiliary stent2022-01-28
    Product approval · Class 3제허 22-68 호
  • FDAHANAROSTENT Esophagus Asymmetric (CCC)2021-11-18
    510(k) · SpecialGeneral, Plastic SurgeryK213251
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), immunological methodRevoked2021-11-04
    Product approval · Class 3체외 제허 21-882 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), immunological methodRevoked2021-08-23
    Product approval · Class 3체외 제허 21-705 호
  • FDAHANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)2021-07-23
    510(k) · TraditionalGeneral, Plastic SurgeryK201160
  • MFDSElectrosurgical system electrode, foot-controlled, single-use2021-07-19
    Product approval · Class 2수인 21-4347 호
  • MFDSColonoscope, video2021-07-06
    Product approval · Class 2수인 21-4319 호
  • MFDSColonoscope, video2021-07-06
    Product approval · Class 2수인 21-4318 호
  • MFDSGastroscope, video2021-06-16
    Product approval · Class 2수인 21-4287 호
  • MFDSOrthopedic materials2021-05-27
    Product approval · Class 3제허 21-420 호
  • MFDSColonoscope, video2021-05-20
    Product approval · Class 2수인 21-4232 호
  • FDAHANAROSTENT Benefit Biliary (NNN)2021-05-11
    510(k) · TraditionalGastroenterology, UrologyK202973
  • MFDSBiliary stent2021-03-25
    Product approval · Class 3제허 21-225 호
  • MFDSBlood glucose meter for self testRevoked2021-03-16
    Product approval · Class 3체외 제허 21-195 호
  • MFDSOrthopedic materials2021-03-16
    Product approval · Class 3제허 21-194 호
  • MFDSIVD strip for glucose self testRevoked2021-03-16
    Product approval · Class 3체외 제허 21-193 호
  • MFDSElectrosurgical system electrode, foot-controlled, single-use2021-02-22
    Product approval · Class 2수인 21-4069 호
  • FDAHANAROSTENT Trachea/Bronchium (CCC)2020-12-31
    510(k) · TraditionalGeneral, Plastic SurgeryK201342
  • MFDSDuodenoscope, video2020-12-17
    Product approval · Class 2수인 20-4818 호
  • MFDSDuodenoscope, video2020-12-17
    Product approval · Class 2수인 20-4817 호
  • MFDSDilator, balloon2020-10-08
    Product approval · Class 2수인 20-4664 호
  • MFDSSystem, medical image processing device2020-10-07
    Product approval · Class 1수신 20-2360 호
  • MFDSSystem, medical image processing device2020-10-07
    Product approval · Class 1수신 20-2358 호
  • MFDSDuodenoscope, video2020-09-22
    Product approval · Class 2수인 20-4638 호
  • MFDSCatheter, general-purpose, balloon2020-09-17
    Product approval · Class 2수인 20-4619 호
  • MFDSElectrosurgical system electrode, foot-controlled, single-use2020-09-17
    Product approval · Class 2수인 20-4618 호
  • MFDSProbe, general-purpose, internal2020-09-17
    Product approval · Class 2수인 20-4617 호
  • MFDSProbe, general-purpose, internal2020-09-17
    Product approval · Class 2수인 20-4616 호
  • MFDSLight source, endoscope2020-09-17
    Product approval · Class 2수인 20-4615 호
  • MFDSUltrasonic endoscope2020-09-17
    Product approval · Class 2수인 20-4614 호
  • MFDSLight source, endoscope2020-09-17
    Product approval · Class 2수인 20-4613 호
  • MFDSGastroscope, video2020-09-17
    Product approval · Class 2수인 20-4612 호
  • MFDSColonoscope, video2020-09-17
    Product approval · Class 2수인 20-4611 호
  • MFDSElectrosurgical system electrode, foot-controlled, single-use2020-09-17
    Product approval · Class 2수인 20-4610 호
  • MFDSUltrasonic endoscope2020-09-15
    Product approval · Class 2수인 20-4603 호
  • MFDSEndotherapy device, general-purpose, single-use2020-09-15
    Product approval · Class 2수인 20-4602 호
  • MFDSDuodenoscope, video2020-09-15
    Product approval · Class 2수인 20-4601 호
  • MFDSSmall inestinoscopeA, fibreoptic, video2020-09-15
    Product approval · Class 2수인 20-4600 호
  • MFDSUltrasound imaging system, general-purpose2020-09-15
    Product approval · Class 2수인 20-4596 호
  • MFDSLight source, endoscope2020-09-15
    Product approval · Class 2수인 20-4595 호
  • MFDSDuodenoscope, video2020-09-15
    Product approval · Class 2수인 20-4594 호
  • MFDSUltrasound imaging system, general-purpose2020-09-15
    Product approval · Class 2수인 20-4593 호

Showing the 80 most recent of 243 records.

R&D and key agreements

Source: DART corporate disclosure

고탄성 형상기억 생분해성 스텐트 개발 · Development of a high-elasticity shape-memory biodegradable stent overcoming the performance limits of existing biodegradable stents; a biodegradable drug-eluting stent designed to dissolve in the body. (Sep 2020-ongoing)

다중 약물방출 생분해성 스텐트 개발 · Development of a multi-drug-eluting biodegradable stent with improved stricture treatment and patency rate. (Oct 2021-ongoing)

생분해성 중재의료기기 개발 [소재부품기술개발사업] · Development of three solvent-free melt-electrospinning (MES)-based biodegradable polymer interventional devices. (Apr 2022-ongoing)

반려동물 생분해성 스텐트 개발 [반려동물전주기산업화기술개발사업] · 반려동물 · Development of three biodegradation-period-controlled non-vascular biodegradable stents (esophageal, urethral, ureteral) for companion animal welfare. (Apr 2023-ongoing)

전기소작용 배액 스텐트 시스템 개선 & MDR 허가 구축 · Product improvement based on customer feedback and pursuit of MDR certification approval. (Mar 2024-ongoing)

중국용 담도 스텐트 개발 · 담도 · Development of a biliary stent to expand the biliary product portfolio in China. (Apr 2024-ongoing)

전기소작용 배액 스텐트 전달 시스템 개발(v2) · Upgrade of the existing v1 delivery system. (Apr 2024-ongoing)

전기소작용 배액 스텐트 개발 - Indication 확장 · Expansion of the procedural indication scope. (Apr 2024-ongoing)

생분해성 스텐트 개발 - 담관 적용 · 담관 · Development of a biodegradable stent applicable to the bile duct. (Jan 2025-ongoing)

제품 원자재 내재화 연구 · Review of cost reduction through localization of imported raw materials and enhancement of key raw-material development capability. (Jan 2025-ongoing)

Short guide wire 제품군 포트폴리오 확장 · 담도 · Expansion of applicable models for the Short guide wire delivery system, currently limited to some biliary models. (Apr 2025-ongoing)

미국용 식도 스텐트 변경 허가 · 식도 · Pursuit of a US regulatory change approval for a product reflecting three coating changes. (Apr 2025-ongoing)

일본 EUS-BD용 제품 개발 · 담도 · Addition of an EUS-BD use to the existing biliary stent. (Apr 2025-ongoing)

환부이탈 방지 비혈관 스텐트 제품군 개발 (산업통상자원부) · Development of an anti-migration GI stent with tissue adhesion and biocompatibility to prevent stent displacement, under a Ministry of Trade, Industry and Energy project. (Jul 2025-ongoing)

국내 담도 Long Lasso스텐트 개발 · 담도 · Expansion of the biliary stent portfolio, expected to increase revenue. (Jul 2025-ongoing)

일본 대장 스텐트(Covered) 개발 · 대장 · Development in response to new requirements in the Japanese market. (Jul 2025-ongoing)

Patents

KIPRIS · applicant-matched
Show 140 more patents

AI reads

MAA server logs · IP-verified
115
Times AI engines pulled MITECH CO.,LTD.'s records

Pulled records become part of each AI's index and keep feeding its answers. When an AI cites from that index, nothing reaches our server — so actual citations are uncounted here and exceed this number.

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Last 7 days
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Last 30 days
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  • GoogleGoogleOther12
  • PerplexityPerplexityBot2
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  • MicrosoftBingbot1

Measured since Aug 27, 2026 · 5 AI engines · last read Oct 10, 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.

Finemedix Co., Ltd.19 shared

KOSDAQ-listed medical device company producing ESD/EMR endoscopic devices such as ClearCut Knife and Clear-Jet Injector.

DONG-A ST CO.,LTD18 shared

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

SEWOONMEDICAL CO,. LTD.14 shared

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

DreamCIS INC.8 shared

Contract research organization providing clinical trial, post-marketing surveillance, and site management services to pharma and medtech clients.

WSI Co., Ltd.5 shared

Founded and KOSDAQ-listed in 2018, WSI distributes spine/joint devices and has expanded into medical robots and pharma via subsidiaries.

LivsMed Inc.5 shared

KOSDAQ-listed minimally invasive surgical device company developing the ArtiSential multi-jointed laparoscopic instrument and ArtiSeal vessel sealer.

JMT CO.,Ltd.4 shared

Provides EMS and SMT manufacturing services for TFT-LCD and OLED panel driver PBAs.

DongKook Life Science Co., Ltd.4 shared

Founded in 2017 and KOSDAQ-listed in 2025, DongKook Life Science makes contrast agent products and distributes medical devices.

NEXTBIOMEDICAL Co., Ltd.4 shared

Founded in 2014 and listed on KOSDAQ in 2024, NEXTBIOMEDICAL develops endoscopic hemostats and vascular embolization microspheres.

GC Medical Science Corporation4 shared

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

Alpha AI Co.,Ltd.4 shared

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

CLASSYS Inc.4 shared

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

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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