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Medical DevicesKOSDAQ 31493022 approvals

BIODYNE CO., LTD.

Official website

Founded in 1999 and KOSDAQ-listed in 2021, BIODYNE develops liquid-based cytology (LBC) devices and diagnostic reagent kits.

As of 2026-10-11, BIODYNE CO., LTD. has 22 Korean MFDS device approvals, 1 PubMed-indexed paper 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 1999 and listed on KOSDAQ in 2021, BIODYNE is a liquid-based cytology (LBC) device and diagnostic reagent company. Using its proprietary Blowing Technology, it supplies LBC devices including PATHPLORER AUTO, PATHPLORER PLUS 4.7, PATHPLORER PLUS 4.63, and PATHPLORER ECO, along with reagent kits such as cell processing solutions, membrane filters, and slides. It exports to 13 countries including Japan, Russia, Portugal, and Thailand, and under a 20-year technology transfer and sales agreement signed with Roche in 2019 worth a USD 6,750,000 milestone, it co-markets the VENTANA SP400 LBC device.

Products & technology

  • PATHPLORER AUTOAutomated liquid-based cytology (LBC) device
  • PATHPLORER PLUS 4.7Semi-automatic LBC device focused on slide production speed
  • PATHPLORER PLUS 4.63LBC device with external air tank
  • PATHPLORER ECOCompact value-oriented LBC device
  • LBC reagent kit (cell processing solution, membrane filter, slide, cell collection brush)Reagents for cancer diagnosis via liquid-based cytology
  • VENTANA SP400LBC cell smearing device co-developed with Roche

Regulatory approvals

data.go.kr

22 Korean MFDS device approvals · 2000–2024

  • MFDSTool for biopsy2024-11-29
    Product approval · Class 2제인 24-1083 호
  • MFDSAuto stainer for pathology2018-03-02
    Product approval · Class 1체외 제신 18-253 호
  • MFDSSample processing instruments2016-02-02
    Product approval · Class 1체외 제신 16-122 호
  • MFDSSpecimen transport media2015-10-30
    Product approval · Class 1체외 제신 15-333 호
  • MFDSTool for biopsy2014-06-30
    Product approval · Class 2제인 14-1230 호
  • MFDSSample processing instruments2014-06-20
    Product approval · Class 1경인 체외 제신 14-394 호
  • MFDSTool for biopsy2013-02-06
    Product approval · Class 2제인 13-343 호
  • MFDSAuto stainer for pathology2012-01-02
    Product approval · Class 1경인 체외 제신 12-3 호
  • MFDSSample processing instruments2007-02-16
    Product approval · Class 1경인 체외 제신 07-39 호
  • MFDS진공채혈관Revoked2006-03-20
    Product approval · Class 1경인 수신 06-514 호
  • MFDSSample processing instruments2005-05-25
    Product approval · Class 1경인 체외 제신 05-69 호
  • MFDS체액분석기Revoked2005-05-09
    Product approval · Class 1경인 제신 05-57 호
Show 10 more
  • MFDS체액분석기Revoked2004-11-15
    Product approval · Class 1경인 제신 04-207 호
  • MFDS개인용저주파자극기Revoked2004-04-30
    Product approval · Class 2제허 04-445 호
  • MFDS의료용조합자극기Revoked2004-01-20
    Product approval · Class 2제허 04-85 호
  • MFDS의료용필름현상기Revoked2002-03-11
    Product approval · Class 1경인 수신 02-512 호
  • MFDS의료용영상출력기Revoked2002-02-06
    Product approval · Class 1경인 수신 02-257 호
  • MFDS의료용필름현상기Revoked2002-02-06
    Product approval · Class 1경인 수신 02-258 호
  • MFDS의료용필름현상기Revoked2001-12-04
    Product approval · Class 1경인 수신 01-3613 호
  • MFDS의료용영상출력기Revoked2001-11-14
    Product approval · Class 1경인 수신 01-3474 호
  • MFDS전산화단층엑스선촬영장치Revoked2001-05-18
    Product approval · Class 2수허 01-575 호
  • MFDS초음파골밀도측정기Revoked2000-08-11
    Product approval · Class 2수허 00-882 호

R&D and key agreements

Source: DART corporate disclosure

블로윙(Blowing) 기술 기반 LBC 장비 고도화 · 자궁경부암 등 세포진단 · In-house R&D center developed PATHPLORER PLUS 4.63/4.7/AUTO devices and carried out multiple government-funded projects

Publications

PubMed · affiliation-matched

Patents

KIPRIS · applicant-matched
Show 32 more patents

AI reads

MAA server logs · IP-verified
61
Times AI engines pulled BIODYNE CO., LTD.'s records

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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.

JW PHARMACEUTICAL4 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.

SHINHUNG CO.,LTD3 shared

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

SEJONG MEDICAL Co.Ltd.,2 shared

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

REMED CO.,LTD.2 shared

KOSDAQ-listed magnetic stimulation medical device company developing TMS-based brain rehabilitation devices and PMS pain management devices.

ValueAddedTechnologyCo.,Ltd.2 shared

Founded in 1992 and KOSDAQ-listed in 2006, VATECH manufactures dental digital X-ray and CT imaging diagnostic devices.

JPI Healthcare Co., Ltd.2 shared

JPI Healthcare, founded 1980, makes X-ray imaging device components and equipment, listed on KOSDAQ in August 2025.

SEEGENE, INC.2 shared

Founded in 2000 and KOSDAQ-listed in 2010, Seegene develops syndromic multiplex PCR molecular diagnostic reagents.

Alpha AI Co.,Ltd.2 shared

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

SD BIOSENSOR INC.2 shared

KOSPI-listed in-vitro diagnostics company known for the STANDARD Q antigen/antibody test kits.

Xcell Therapeutics Inc.1 shared

Xcell Therapeutics develops the domestically produced CellCor™ cell culture media series for cell and gene therapy manufacturing.

GC Medical Science Corporation1 shared

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

CU MEDICAL SYSTEMS Inc.1 shared

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

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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