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Medical DevicesKONEX 19929073 approvals

BIO PROTECH INC.

Official website

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

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Market cap

Business overview

Source: DART corporate disclosure

Founded in 2000 and listed on KONEX in 2016, Bio Protech is a medical device company specializing in biosensors. It supplies biosensor products such as ECG measurement electrodes for the electronic medical device consumables market. Building on its existing technology, it is conducting R&D to develop medical biosensor products.

Products & technology

  • ECG measurement electrodesBiosensor consumable for electronic medical devices

Regulatory approvals

data.go.kr · openFDA

66 Korean MFDS device approvals · 2001–2026 / 7 US FDA 510(k) · 2008–2019

  • MFDSElectrode, electroencephalograph, scalp2026-06-05
    Product approval · Class 1제신 26-691 호
  • MFDSElectrode, electroencephalograph, scalp2026-05-27
    Product approval · Class 1제신 26-653 호
  • MFDSElectrosurgical system electrode, hand-controlled, general-purpose, single-use2025-07-11
    Product approval · Class 2제인 25-4623 호
  • MFDSCatheter, evacuator2024-09-24
    Product approval · Class 1제신 24-1175 호
  • MFDSElectrode, electroencephalograph, scalp2024-09-19
    Product approval · Class 1수신 24-1746 호
  • MFDSGel for medical use, non-sterilized2024-08-27
    Product approval · Class 1수신 24-1596 호
  • MFDSSuction system, surgical wound2024-06-20
    Product approval · Class 2제인 24-603 호
  • MFDSSuction system, surgical wound2024-05-22
    Product approval · Class 2제인 24-507 호
  • MFDSElectrode, external2024-05-21
    Product approval · Class 1제신 24-618 호
  • MFDSElectrode, external2024-02-15
    Product approval · Class 1제신 24-197 호
  • MFDSElectrosurgical system electrode, hand-controlled, general-purpose, single-use2024-01-16
    Product approval · Class 2제인 24-53 호
  • MFDSElectrode, electrocardiograph, single-use2023-09-26
    Product approval · Class 1제신 23-1437 호
Show 61 more
  • MFDSElectrocardiograph electrode, neonatal2023-09-22
    Product approval · Class 1제신 23-1426 호
  • MFDSProbe, general-purpose, external2023-08-07
    Product approval · Class 1제신 23-1207 호
  • MFDSElectrode, external2023-08-04
    Product approval · Class 1제신 23-1203 호
  • MFDSSuction system, surgical wound2021-02-10
    Product approval · Class 2제인 21-4113 호
  • FDAEvaQMax Smoke Evacuation System2019-08-29
    510(k) · TraditionalGeneral, Plastic SurgeryK192035
  • MFDSElectrosurgical system electrode, hand-controlled, general-purpose, single-use2019-01-29
    Product approval · Class 2제인 19-4071 호
  • MFDSElectrode, electrocardiograph, single-use2018-10-31
    Product approval · Class 1수신 18-2385 호
  • MFDSElectrode, electrocardiograph, single-use2018-02-12
    Product approval · Class 1제신 18-182 호
  • MFDSElectrode, electrocardiograph, single-use2017-09-07
    Product approval · Class 1수신 17-2724 호
  • FDADisposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes2016-06-03
    510(k) · TraditionalPhysical MedicineK152984
  • FDADisposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes2016-03-21
    510(k) · TraditionalNeurologyK153019
  • MFDSElectrode, electromyograph, internal2015-11-24
    Product approval · Class 2제인 15-4303 호
  • FDAPROPENCIL Smoke Pencil2015-07-16
    510(k) · TraditionalGeneral, Plastic SurgeryK143103
  • MFDSElectrode, electrocardiograph, single-use2015-04-13
    Product approval · Class 1서울 제신 15-134 호
  • FDACUTANEOUS ELECTRODES2014-11-17
    510(k) · TraditionalNeurologyK142099
  • MFDSElectrode, external2014-09-23
    Product approval · Class 1서울 수신 14-2443 호
  • MFDSElectrode, external2014-09-23
    Product approval · Class 1서울 수신 14-2442 호
  • MFDSElectrode, external2014-08-21
    Product approval · Class 1서울 수신 14-2256 호
  • MFDSElectrode, electrocardiograph, single-use2014-08-21
    Product approval · Class 1서울 수신 14-2257 호
  • MFDSElectrode, external2014-08-21
    Product approval · Class 1서울 수신 14-2258 호
  • MFDSProbe, general-purpose, external2014-06-09
    Product approval · Class 1서울 수신 14-1655 호
  • MFDSElectrosurgical system electrode, hand-controlled, general-purpose, single-useRevoked2014-05-26
    Product approval · Class 3제허 14-1081 호
  • MFDSElectrode, externalRevoked2014-04-07
    Product approval · Class 1서울 제신 14-168 호
  • MFDSElectrode, electrocardiograph, single-useRevoked2014-03-24
    Product approval · Class 1서울 제신 14-148 호
  • MFDSElectrosurgical system electrode, hand-controlled, general-purpose, single-useRevoked2014-02-20
    Product approval · Class 3제허 14-450 호
  • MFDSElectrode, externalRevoked2013-08-26
    Product approval · Class 1서울 제신 13-247 호
  • MFDSElectrode, electrocardiograph, single-useRevoked2013-08-26
    Product approval · Class 1서울 제신 13-246 호
  • MFDSElectrode, externalRevoked2013-08-26
    Product approval · Class 1서울 제신 13-245 호
  • MFDSProbe, general-purpose, externalRevoked2013-08-26
    Product approval · Class 1서울 제신 13-244 호
  • MFDSElectrode, electrocardiograph, single-useRevoked2013-05-29
    Product approval · Class 1서울 제신 13-171 호
  • MFDSElectrode, electrocardiograph, single-use2013-04-17
    Product approval · Class 1서울 제신 13-97 호
  • MFDSProbe, general-purpose, externalRevoked2012-09-06
    Product approval · Class 1서울 제신 12-195 호
  • MFDSProbe, general-purpose, external2012-02-09
    Product approval · Class 1서울 제신 12-29 호
  • MFDSElectrosurgical system electrode, hand-controlled, general-purpose, single-use2011-07-15
    Product approval · Class 2제인 11-778 호
  • MFDSStimulator, microwave, interference2011-03-07
    Product approval · Class 2제인 11-250 호
  • MFDSNeedle-electrode, electric stimulator2010-07-29
    Product approval · Class 2제인 10-751 호
  • MFDSElectrosurgical system electrode, hand-controlled, general-purpose, single-use2010-04-05
    Product approval · Class 2제인 10-307 호
  • FDAPROPENCIL ESU PENCIL2009-11-25
    510(k) · TraditionalGeneral, Plastic SurgeryK092732
  • MFDSProbe, general-purpose, external2009-08-14
    Product approval · Class 1서울 제신 09-172 호
  • MFDSStimulator, electrical, home-use2009-07-01
    Product approval · Class 2제인 09-485 호
  • MFDSStimulator, electrical, home-use2009-07-01
    Product approval · Class 2제인 09-484 호
  • MFDS의료용프로브(체외형)Revoked2009-06-17
    Product approval · Class 1서울 제신 09-104 호
  • MFDS전기수술기용전극Revoked2009-06-10
    Product approval · Class 2제허 09-439 호
  • MFDSElectrode, electrocardiograph, single-useRevoked2009-04-07
    Product approval · Class 1서울 제신 09-58 호
  • MFDSLow frequency electric stimulator for medical use, home use2009-02-09
    Product approval · Class 2제허 09-94 호
  • MFDSElectrode, externalRevoked2008-12-30
    Product approval · Class 1서울 제신 08-282 호
  • MFDSElectrode, externalRevoked2008-12-30
    Product approval · Class 1서울 제신 08-281 호
  • FDATELECTRODE WET GEL ECG ELECTRODE2008-11-07
    510(k) · TraditionalCardiovascularK083148
  • MFDSElectrode, electrocardiograph, single-useRevoked2008-09-04
    Product approval · Class 1서울 제신 08-212 호
  • MFDSElectrode, external2008-06-02
    Product approval · Class 1서울 제신 08-153 호
  • MFDSElectrode, electrocardiograph, single-use2008-03-05
    Product approval · Class 1서울 제신 08-40 호
  • MFDSElectrode, electrocardiograph, single-use2008-03-03
    Product approval · Class 1서울 제신 08-38 호
  • MFDSLow frequency electric stimulator for medical use, home use2007-12-14
    Product approval · Class 2제인 07-709 호
  • MFDSLow frequency electric stimulator for medical use, home use2007-12-14
    Product approval · Class 2제인 07-708 호
  • MFDS의료용전극(체외용)Revoked2007-04-11
    Product approval · Class 1서울 제신 07-65 호
  • MFDS의료용전극Revoked2005-08-10
    Product approval · Class 1서울 제신 05-115 호
  • MFDS의료용전극Revoked2005-08-10
    Product approval · Class 1서울 제신 05-101 호
  • MFDSProbe, general-purpose, external2004-01-19
    Product approval · Class 1서울 제신 04-15 호
  • MFDSElectrode, electrocardiograph, single-use2001-05-10
    Product approval · Class 1서울 제신 01-29 호
  • MFDSElectrode, external2001-05-10
    Product approval · Class 1서울 제신 01-30 호
  • MFDSElectrode, external2001-05-10
    Product approval · Class 1서울 제신 01-31 호

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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.

CU MEDICAL SYSTEMS Inc.7 shared

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

MEDIANA Co.,LTD6 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.

SHINHUNG CO.,LTD5 shared

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

ASTERASYS Co., Ltd.4 shared
WON TECH CO.,Ltd.4 shared

Founded in 2019 and KOSDAQ-listed the same year, WON TECH makes aesthetic laser, RF, and HIFU devices including Oligio and Picocare.

CLASSYS Inc.4 shared

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

SEJONG MEDICAL Co.Ltd.,3 shared

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

SEERS Co., Ltd.3 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., Ltd2 shared

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

Alpha AI Co.,Ltd.2 shared

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

BTB Korea Co.,Ltd2 shared

KOSDAQ-listed aesthetic medical device company producing PICO, DUAL HI, and other anti-aging and body-contouring devices.

CELLUMED CO., LTD.2 shared

KOSDAQ-listed holding company making medical devices and biologics including bone graft rhBMP2 and knee implant TKR.

Sources and updates

Company basics
Korea Exchange · DART
Business content
Compiled from disclosure filings
AI visibility
Measured 2026-08-13

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