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Medical DevicesKOSDAQ 064550140 approvals1 trials

BIONEERCORPORATION

Official website

Bioneer, founded in 1992 and KOSDAQ-listed in 2005, provides gene analysis equipment, molecular diagnostics, and RNAi drug development.

As of 2026-10-11, BIONEERCORPORATION has 140 Korean MFDS device approvals, 94 PubMed-indexed papers 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 1992 and listed on KOSDAQ in 2005, Bioneer is a biohealthcare company specializing in life science research products, molecular diagnostics, and RNAi-based drug development. It supplies PCR instruments, real-time quantitative PCR systems, the cell-free protein synthesis/purification system ExiProgen™, and the field-deployable real-time PCR system IRON-qPCR™, while subsidiary Ssenagen develops a fibrosis treatment using the SAMiRNA™ siRNA platform. It reinvests 30-40% of revenue into R&D and exports products to more than 50 countries.

Regulatory approvals

data.go.kr

140 Korean MFDS device approvals · 2009–2026

  • MFDSIVD reagents for genotyping or patient monitoring of HIV, HBV, HCV, HTLV, molecular diagnostics2026-09-22
    Product approval · Class 3체외 제허 26-716 호
  • MFDSIVD reagents for genotyping or patient monitoring of HIV, HBV, HCV, HTLV, molecular diagnostics2026-04-20
    Product approval · Class 3체외 제허 26-297 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), molecular diagnostics2024-12-06
    Product approval · Class 3체외 제허 24-860 호
  • MFDSIVD reagents for extracting nucleic acids2024-09-10
    Product approval · Class 1체외 제신 24-1142 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), molecular diagnostics2024-09-09
    Product approval · Class 3체외 제허 24-618 호
  • MFDSIVD reagents for extracting nucleic acids2024-08-19
    Product approval · Class 1체외 제신 24-1046 호
  • MFDSIVD reagents for extracting nucleic acids2024-08-19
    Product approval · Class 1체외 제신 24-1045 호
  • MFDSIVD reagents for extracting nucleic acids2024-08-13
    Product approval · Class 1체외 제신 24-1025 호
  • MFDSIVD reagents for extracting nucleic acids2024-08-07
    Product approval · Class 1체외 제신 24-1008 호
  • MFDSIVD reagents for extracting nucleic acids2024-07-03
    Product approval · Class 1체외 제신 24-832 호
  • MFDSIVD reagents for extracting nucleic acids2024-07-02
    Product approval · Class 1체외 제신 24-820 호
  • MFDSReal-time gene amplificator, nucleic acid2024-02-01
    Product approval · Class 2체외 제인 24-124 호
Show 68 more
  • 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), molecular diagnostics2023-11-30
    Product approval · Class 3체외 제허 23-1100 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), molecular diagnostics2023-11-09
    Product approval · Class 3체외 제허 23-1047 호
  • MFDSIVD reagents for extracting nucleic acids2023-11-01
    Product approval · Class 1체외 제신 23-1582 호
  • MFDSIVD reagents for extracting nucleic acids2023-08-03
    Product approval · Class 1체외 제신 23-1195 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), molecular diagnostics2023-06-14
    Product approval · Class 3체외 제허 23-665 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), molecular diagnostics2023-06-14
    Product approval · Class 3체외 제허 23-664 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), molecular diagnostics2023-05-17
    Product approval · Class 3체외 제허 23-587 호
  • MFDSIVD reagents for extracting nucleic acids2023-02-28
    Product approval · Class 1체외 제신 23-236 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), molecular diagnostics2023-01-25
    Product approval · Class 3체외 제허 23-56 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), molecular diagnosticsRevoked2023-01-18
    Product approval · Class 3체외 제허 23-40 호
  • MFDSReal-time gene amplificator, nucleic acid2023-01-18
    Product approval · Class 2체외 제인 23-4070 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), molecular diagnostics2023-01-12
    Product approval · Class 3체외 제허 23-24 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), molecular diagnostics2022-09-06
    Product approval · Class 3체외 제허 22-597 호
  • MFDSIVD reagents for extracting nucleic acids2022-05-03
    Product approval · Class 1체외 제신 22-605 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), molecular diagnostics2022-04-25
    Product approval · Class 3체외 제허 22-262 호
  • MFDSIVD reagents for extracting nucleic acidsRevoked2022-04-18
    Product approval · Class 1체외 제신 22-514 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), molecular diagnosticsRevoked2022-03-22
    Product approval · Class 3체외 제허 22-202 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), molecular diagnosticsRevoked2022-01-27
    Product approval · Class 3체외 제허 22-66 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), molecular diagnosticsRevoked2022-01-27
    Product approval · Class 3체외 제허 22-65 호
  • MFDSTool for specimens2021-10-27
    Product approval · Class 1수신 21-1929 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), molecular diagnostics2021-10-25
    Product approval · Class 3체외 제허 21-859 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), molecular diagnosticsRevoked2021-09-29
    Product approval · Class 3체외 제허 21-812 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), molecular diagnosticsRevoked2021-09-29
    Product approval · Class 3체외 제허 21-809 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), molecular diagnosticsRevoked2021-09-29
    Product approval · Class 3체외 제허 21-808 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), molecular diagnosticsRevoked2021-09-24
    Product approval · Class 3체외 제허 21-791 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), molecular diagnosticsRevoked2021-09-24
    Product approval · Class 3체외 제허 21-792 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), molecular diagnosticsRevoked2021-09-24
    Product approval · Class 3체외 제허 21-793 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), molecular diagnostics2021-09-13
    Product approval · Class 3체외 제허 21-765 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), molecular diagnostics2021-05-26
    Product approval · Class 3체외 제허 21-413 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), molecular diagnostics2021-04-30
    Product approval · Class 3체외 제허 21-339 호
  • MFDSGeneral gene amplificator, nucleic acid, without fluorescence meter2021-03-19
    Product approval · Class 1체외 제신 21-361 호
  • MFDSIVD reagents for extracting nucleic acids2021-03-15
    Product approval · Class 1체외 제신 21-330 호
  • MFDSSpecimen transport media2021-01-28
    Product approval · Class 1체외 제신 21-119 호
  • MFDSIVD reagents for extracting nucleic acidsRevoked2020-11-20
    Product approval · Class 1체외 제신 20-1685 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), molecular diagnostics2020-10-28
    Product approval · Class 3체외 제허 20-917 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), molecular diagnostics2020-10-28
    Product approval · Class 3체외 제허 20-915 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), molecular diagnostics2020-10-28
    Product approval · Class 3체외 제허 20-913 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), molecular diagnostics2020-06-05
    Product approval · Class 3체외 제허 20-453 호
  • MFDSIVD reagents for extracting nucleic acids2020-04-21
    Product approval · Class 1체외 제신 20-554 호
  • MFDSIVD reagents for extracting nucleic acidsRevoked2020-04-13
    Product approval · Class 1체외 제신 20-511 호
  • MFDSIVD reagents for extracting nucleic acids2020-04-07
    Product approval · Class 1체외 제신 20-491 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), molecular diagnosticsRevoked2020-03-31
    Product approval · Class 3체외 제허 20-232 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), molecular diagnosticsRevoked2020-03-31
    Product approval · Class 3체외 제허 20-231 호
  • MFDSIVD reagents for extracting nucleic acids2020-03-04
    Product approval · Class 1체외 제신 20-282 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), molecular diagnostics2020-01-29
    Product approval · Class 3체외 제허 20-55 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), molecular diagnostics2020-01-20
    Product approval · Class 3체외 제허 20-40 호
  • MFDSReal-time gene amplificator, nucleic acid2019-12-30
    Product approval · Class 2체외 제인 19-5058 호
  • MFDSIVD reagents for cancer related geneRevoked2019-09-19
    Product approval · Class 3체외 제허 19-598 호
  • MFDSIVD reagents for genotyping or patient monitoring of HIV, HBV, HCV, HTLV, molecular diagnostics2019-01-29
    Product approval · Class 3체외 제허 19-79 호
  • MFDSIVD reagents for extracting nucleic acidsRevoked2018-11-01
    Product approval · Class 1체외 제신 18-1454 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), molecular diagnostics2018-10-31
    Product approval · Class 3체외 제허 18-712 호
  • MFDSIVD reagents for extracting nucleic acids2018-06-15
    Product approval · Class 1체외 제신 18-728 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), molecular diagnostics2018-06-07
    Product approval · Class 3체외 제허 18-403 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), molecular diagnostics2018-06-07
    Product approval · Class 3체외 제허 18-402 호
  • MFDSIVD reagents for extracting nucleic acids2018-05-15
    Product approval · Class 1체외 제신 18-593 호
  • MFDSReal-time gene amplificator, nucleic acid2018-05-14
    Product approval · Class 2체외 제인 18-4360 호
  • MFDSReal-time gene amplificator, nucleic acid2018-05-02
    Product approval · Class 2체외 제인 18-4335 호
  • MFDSIVD reagents for extracting nucleic acids2018-04-11
    Product approval · Class 1체외 제신 18-436 호
  • MFDSExtractor, nucleic acid2018-03-22
    Product approval · Class 1체외 제신 18-344 호
  • MFDSIVD reagents for extracting nucleic acids2017-09-19
    Product approval · Class 1체외 제신 17-1098 호
  • MFDSReal-time gene amplificator, nucleic acid2017-09-04
    Product approval · Class 2체외 제인 17-4699 호
  • MFDSIVD reagents for extracting nucleic acids2017-08-30
    Product approval · Class 1체외 제신 17-1010 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), molecular diagnostics2017-07-17
    Product approval · Class 3체외 제허 17-511 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), molecular diagnosticsRevoked2017-02-02
    Product approval · Class 3체외 제허 17-90 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), molecular diagnosticsRevoked2017-02-02
    Product approval · Class 3체외 제허 17-89 호
  • MFDSExtractor, nucleic acid2016-11-25
    Product approval · Class 1체외 제신 16-1423 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), molecular diagnostics2016-08-25
    Product approval · Class 3체외 제허 16-630 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), molecular diagnostics2016-03-09
    Product approval · Class 3체외 제허 16-174 호

Showing the 80 most recent of 140 records.

Clinical trials

data.go.kr

1 MFDS clinical trial authorisations · 2025 (Phase 1b 1)

  • Phase 1bSRN001 90 mg 정주(SRN001)2025-12-04

    3 trial sites

Global clinical trials

ClinicalTrials.gov · sponsor-matched

Publications

PubMed · affiliation-matched
Show 84 more publications

Patents

KIPRIS · applicant-matched
Show 421 more patents

AI reads

MAA server logs · IP-verified
87
Times AI engines pulled BIONEERCORPORATION'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.

0
Fetched fresh mid-answer

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.

87
Index crawls

Collected as raw material for future answers.

0
Direct AI-tool queries (MCP)

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

10
live 0
Last 7 days
70
live 0
Last 30 days
87
live 0
All time
  • OpenAIOAI-SearchBot68
  • GoogleGoogleOther8
  • PerplexityPerplexityBot7
  • MicrosoftBingbot2
  • AnthropicClaudeBot2

Measured since Aug 27, 2026 · 5 AI engines · last read Oct 10, 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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Connect it to ChatGPT or Claude, and your AI queries the full record — profiles, financials, stock data, regulatory approvals, clinical trials, publications and patents — for BIONEERCORPORATION and every listed Korean medical, bio and AI company.

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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.

SEEGENE, INC.9 shared

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

LabGenomics. Co., Ltd.8 shared

KOSDAQ-listed molecular genetic diagnostics company providing NGS-based non-invasive prenatal testing (NIPT) under the MomGuard brand.

RollingStone Co., Ltd.7 shared

KOSDAQ-listed in-vitro diagnostics company developing the LabChip-based VERI-Q molecular diagnostic device series.

OSANG HEALTHCARE CO.,LTD.6 shared

Founded 1996, listed on KOSDAQ in 2024, OSANG HEALTHCARE develops and sells biochemistry, immunodiagnostic, and molecular IVD products.

GC Medical Science Corporation6 shared

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

Boditech Med Inc.5 shared

KOSDAQ-listed point-of-care immunodiagnostics company supplying diagnostic cartridges and the ichroma/AFIAS instrument series.

HLB PANAGENE Co., LTD.5 shared

Founded in 1976 and KOSDAQ-listed in 2000, HLB PANAGENE develops PNA-based molecular diagnostic and diagnostic automation products.

Access Bio, Inc.5 shared

Founded in 2002 and KOSDAQ-listed in 2013, Access Bio develops rapid diagnostic tests for malaria, COVID-19, and other infectious diseases.

Genesystem Co., Ltd5 shared

Founded 2010, listed on KOSDAQ in 2021, Genesystem develops molecular diagnostic systems, biochips, test kits, and reaction reagents.

Genomictree Inc.5 shared

Cancer molecular diagnostics company behind the EarlyTect-C stool-based colorectal cancer test using the SDC2 methylation biomarker.

SD BIOSENSOR INC.5 shared

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

Gencurix Inc.4 shared

Founded 2011, KOSDAQ-listed 2020, Gencurix develops liquid-biopsy diagnostics: breast cancer prognosis and lung/colorectal companion tests.

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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