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Medical DevicesKOSDAQ 064550139 approvals1 trials

BIONEERCORPORATION

Official website

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

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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

139 Korean MFDS device approvals · 2009–2026

  • 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
  • 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
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 diagnostics2023-11-09
    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
  • 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 diagnosticsRevoked2015-11-19
    Product approval · Class 3체외 제허 15-1597 호

Showing the 80 most recent of 139 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

Not yet compiled: business overview · products · R&D. Send us materials and we will add them

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.

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.

PCL. Inc4 shared

KOSDAQ-listed IVD company using SG Cap™ multiplex diagnostic technology for infectious disease, cancer, and companion animal testing.

HLB PANAGENE Co., LTD.4 shared

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

Sources and updates

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

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