Medical AI Alliance
Company Index
Medical DevicesKOSDAQ 36325027 approvals

Genesystem Co., Ltd

Official website

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

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Market cap

Business overview

Source: DART corporate disclosure

Genesystem was established in March 2010 and listed on the KOSDAQ market in May 2021. Its main business is the development, manufacturing, and service of molecular diagnostic solutions, with product lines including molecular diagnostic systems, biochips, test kits, and reaction reagents. Consolidated revenue for 2025 was KRW 381 million, of which 45.52% came from exports, with products supplied through direct and indirect (distributor) sales domestically and abroad as well as OEM supply contracts.

Products & technology

  • Molecular diagnostic systemPoint-of-care molecular diagnostics
  • BiochipReagent-embedded test chip
  • Test kitDiagnostic testing
  • Reaction reagentDiagnostic reagent

Regulatory approvals

data.go.kr

27 Korean MFDS device approvals · 2016–2025

  • MFDSReal-time gene amplificator, nucleic acid2025-07-25
    Product approval · Class 2체외 제인 25-4668 호
  • MFDSIVD reagents for diagnosis of HIV, HBV, HCV, HTLV, molecular diagnostics2024-11-13
    Product approval · Class 4체외 제허 24-797 호
  • MFDSIVD reagents for diagnosis of HIV, HBV, HCV, HTLV, molecular diagnostics2024-11-13
    Product approval · Class 4체외 제허 24-793 호
  • MFDSIVD reagents for diagnosis of HIV, HBV, HCV, HTLV, molecular diagnostics2024-05-08
    Product approval · Class 4체외 제허 24-318 호
  • MFDSIVD reagents for diagnosis of HIV, HBV, HCV, HTLV, molecular diagnostics2024-05-08
    Product approval · Class 4체외 제허 24-317 호
  • MFDSExtractor, nucleic acid2023-08-10
    Product approval · Class 1체외 제신 23-1226 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 diagnostics2023-03-31
    Product approval · Class 3체외 제허 23-459 호
  • MFDSIVD reagents for extracting nucleic acids2022-11-07
    Product approval · Class 1체외 제신 22-1549 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 diagnostics2022-10-14
    Product approval · Class 3체외 제허 22-688 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 diagnostics2022-09-14
    Product approval · Class 3체외 제허 22-616 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 diagnostics2022-05-26
    Product approval · Class 3체외 제허 22-342 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 diagnostics2022-01-26
    Product approval · Class 3체외 제허 22-62 호
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  • 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 diagnostics2022-01-26
    Product approval · Class 3체외 제허 22-61 호
  • MFDSIVD reagents for extracting nucleic acids2021-12-29
    Product approval · Class 1체외 수신 21-2368 호
  • MFDSExtractor, nucleic acid2021-12-22
    Product approval · Class 1체외 수신 21-2310 호
  • MFDSIVD reagents for extracting nucleic acids2021-12-07
    Product approval · Class 1체외 제허 21-987 호
  • MFDSIVD reagents for extracting nucleic acids2021-12-07
    Product approval · Class 1체외 제허 21-986 호
  • MFDSReal-time gene amplificator, nucleic acid2021-10-28
    Product approval · Class 2체외 제인 21-4919 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 diagnostics2021-07-08
    Product approval · Class 3체외 제허 21-575 호
  • MFDSReal-time gene amplificator, nucleic acid2021-06-04
    Product approval · Class 2체외 제인 21-4480 호
  • MFDSIVD reagents for extracting nucleic acids2021-04-05
    Product approval · Class 1체외 제허 21-255 호
  • MFDSIVD reagents for extracting nucleic acids2021-04-05
    Product approval · Class 1체외 제허 21-254 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 diagnostics2021-03-25
    Product approval · Class 3체외 제허 21-217 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 diagnostics2020-04-16
    Product approval · Class 3체외 제허 20-291 호
  • MFDSReal-time gene amplificator, nucleic acid2020-01-30
    Product approval · Class 2체외 제인 20-4072 호
  • MFDSReal-time gene amplificator, nucleic acid2016-10-04
    Product approval · Class 2체외 제인 16-4772 호
  • MFDSTube, blood collecting, sealed, evacuatedRevoked2016-05-24
    Product approval · Class 1체외 제신 16-641 호

R&D and key agreements

Source: DART corporate disclosure

입자기반 다중 PCR 기술(LEM-PIN) 활용 호흡기 4종 진단키트 개발 · 호흡기 질환 · 개발 중 · Developing four respiratory diagnostic test kits using particle-based multiplex PCR (LEM-PIN) technology licensed in from the Korea Institute of Science and Technology (KIST).

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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.

BIONEERCORPORATION5 shared

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

GC Medical Science Corporation5 shared

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

RollingStone Co., Ltd.5 shared

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

SEEGENE, INC.5 shared

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

Boditech Med Inc.4 shared

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

SD BIOSENSOR INC.4 shared

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

CALTH. Inc3 shared

Holds manufacturing approvals for 42 point-of-care diagnostic reagents and devices in the IVD market.

GENOLUTION INC.3 shared

Founded in 2006 and listed on KOSDAQ in 2020, Genolution is a molecular diagnostics and RNAi company producing nucleic acid extraction reagents and devices.

HLB PANAGENE Co., LTD.3 shared

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

iNtRON Biotechnology, Inc.3 shared

Founded in 1999 and listed on KOSDAQ in 2011, iNtRON Biotechnology develops bacteriophage-based new drugs via its itLysin and IMPA platforms alongside a molecular diagnostics business.

OSANG HEALTHCARE CO.,LTD.3 shared

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

PCL. Inc2 shared

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

Sources and updates

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

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