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Medical DevicesKONEX 19929074 approvals

BIO PROTECH INC.

Official website

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

As of 2026-10-11, BIO PROTECH INC. has 67 Korean MFDS device approvals, 7 US FDA clearances/approvals on record (counted by the MAA Company Index from its own matching of public databases).

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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

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

  • MFDSElectrosurgical system electrode, hand-controlled, general-purpose, single-use2026-09-21
    Product approval · Class 2제인 26-4866 호
  • 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
Show 62 more
  • MFDSElectrode, electrocardiograph, single-use2023-09-26
    Product approval · Class 1제신 23-1437 호
  • 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, externalRevoked2009-08-14
    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

Patents

KIPRIS · applicant-matched
Show 18 more patents

AI reads

MAA server logs · IP-verified
83
Times AI engines pulled BIO PROTECH INC.'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.

2
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Times an AI needed something not yet in its index and fetched this page fresh while answering. Citations served from the index leave no trace here.

81
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0
Direct AI-tool queries (MCP)

Queries from users who connected this index to their own AI.

9
live 0
Last 7 days
72
live 1
Last 30 days
83
live 2
All time
  • OpenAIChatGPT-Userlive2
  • OpenAIOAI-SearchBot71
  • PerplexityPerplexityBot6
  • GoogleGoogleOther2
  • AnthropicClaudeBot2

Measured since Aug 26, 2026 · 4 AI engines · last read Oct 9, 2026

User-agent strings can be forged, so we do not count them at face value. We count only requests matched against vendor-published IP ranges, or confirmed by forward-verified reverse DNS. MCP queries are actual calls to this index's tool endpoint.

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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

Founded in 2015 and listed on KOSDAQ in 2025, ASTERASYS manufactures HIFU and RF-based aesthetic skin devices.

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.

BTB Korea Co.,Ltd2 shared

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

Alpha AI Co.,Ltd.2 shared

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

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

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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