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Medical DevicesKOSDAQ 24672017 approvals

ASTA Co., Ltd.

Official website

Founded in 2006 and KOSDAQ-listed in 2017, ASTA develops MALDI-TOF mass spectrometry diagnostic and industrial systems.

As of 2026-10-10, ASTA Co., Ltd. has 17 Korean MFDS device approvals, 14 PubMed-indexed papers 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 2006 and listed on KOSDAQ in 2017, ASTA is a company developing MALDI-TOF mass spectrometry-based diagnostic and industrial systems. It offers the MicroIDsys (LT/Elite/Cyclone) microbial identification system, the MALDI-TOF RT (NosIDsys) cancer diagnostic system, the OAsys LDI-TOF system for the display industry, the LDI-TOF Premier for battery QC, and the GM-TOF for semiconductor process inspection. It has built a microbial database covering more than 5,000 species, received Korea's Prime Minister's Award for Technology in 2016, the IR52 Jang Young Sil Award in 2022, and the Commissioner of the Korean Intellectual Property Office Award in 2024, and exports its products to markets including Taiwan.

Products & technology

  • MicroIDsys (LT/Elite/Cyclone)Identification of bacterial, fungal, and mycobacterial infections
  • MALDI-TOF RT (NosIDsys)Cancer diagnosis (including breast cancer)
  • LDI-TOF (OAsys)Display panel quality inspection
  • LDI-TOF PremierQuality control inspection for EV batteries
  • GM-TOF (Gas Monitoring)Semiconductor process gas monitoring
  • Sample pretreatment kits (Sepsi Kit, Mold Kit, Myco Kit)Sample pretreatment for sepsis, fungal, and mycobacterial testing

Regulatory approvals

data.go.kr

17 Korean MFDS device approvals · 2013–2024

  • MFDSOther Reagents, classⅠ, for clinical microbiology2024-07-30
    Product approval · Class 1체외 제신 24-979 호
  • MFDSMicrobial identification analyzer2022-01-05
    Product approval · Class 1체외 제신 22-20 호
  • MFDSOther Reagents, classⅠ, for clinical microbiologyRevoked2021-06-03
    Product approval · Class 1체외 제신 21-809 호
  • MFDSOther Reagents, classⅠ, for clinical microbiology2021-06-02
    Product approval · Class 1체외 제신 21-803 호
  • MFDSMicrobial identification analyzer2021-01-14
    Product approval · Class 1체외 제신 21-45 호
  • MFDSOther reagent of sample preparation kit2020-11-16
    Product approval · Class 1체외 제신 20-1661 호
  • MFDSOther Reagents, classⅠ, for clinical microbiology2020-02-20
    Product approval · Class 1체외 제신 20-208 호
  • MFDSMicrobial identification analyzer2019-04-19
    Product approval · Class 1체외 제신 19-506 호
  • MFDSOther Reagents, classⅠ, for clinical microbiology2019-01-22
    Product approval · Class 1체외 제신 19-136 호
  • MFDSOther Reagents, classⅠ, for clinical microbiology2018-05-08
    Product approval · Class 1체외 제신 18-550 호
  • MFDSOther Reagents, classⅠ, for clinical microbiology2018-01-09
    Product approval · Class 1체외 제신 18-33 호
  • MFDSOther Reagents, classⅠ, for clinical microbiology2017-09-06
    Product approval · Class 1체외 제신 17-1040 호
Show 5 more
  • MFDSMicrobial identification analyzer2016-11-17
    Product approval · Class 1체외 제신 16-1369 호
  • MFDSGeneral calibrators, controls or standards, classⅠ, for clinical chemistry2016-10-17
    Product approval · Class 1체외 제신 16-1236 호
  • MFDSOther Reagents, classⅠ, for clinical microbiology2016-10-07
    Product approval · Class 1체외 제신 16-1212 호
  • MFDSSpectrophotometer for clinical use2013-12-18
    Product approval · Class 1경인 체외 제신 13-608 호
  • MFDSSample processing instrumentsRevoked2013-08-05
    Product approval · Class 1경인 체외 제신 13-334 호

R&D and key agreements

Source: DART corporate disclosure

MicroIDsys LT(MALDI-TOF LT) · 세균감염 진단 · 개발완료(2015) · Built a database covering more than 5,000 bacterial species

NosIDsys(MALDI-TOF RT) · 암(유방암 등) · 개발중(2018~) · Building databases for cancers including breast cancer and preparing for regulatory approval and sales

LDI-TOF(OAsys) · 디스플레이 산업용 품질검사 · 개발완료(2019~2021) · Sales to OLED companies began in 2021

Key disclosures

KRX KIND via OpenDART

Publications

PubMed · affiliation-matched
Show 4 more publications

Patents

KIPRIS · applicant-matched
Show 33 more patents

AI reads

MAA server logs · IP-verified
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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.

Boditech Med Inc.3 shared

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

PROTIA INC.3 shared

KOSDAQ-listed in-vitro diagnostics company selling PROTIA Allergy-Q allergy diagnostic products domestically and in 80+ countries.

GC Medical Science Corporation3 shared

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

OSANG HEALTHCARE CO.,LTD.2 shared

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

i-SENS, Inc.2 shared

Founded in 2000 and KOSDAQ-listed in 2013, i-SENS makes blood glucose monitors and point-of-care testing devices.

Sugentech, Inc.2 shared

Founded in 2011 and KOSDAQ-listed in 2019, Sugentech develops multiplex immunoblot, point-of-care, and digital healthcare diagnostics.

Access Bio, Inc.2 shared

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

SD BIOSENSOR INC.2 shared

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

NanoenTek,Inc.1 shared

Founded in 1987 and listed on KOSDAQ in 2000, NanoenTek develops Lab-On-a-Chip in-vitro diagnostic devices and life science instruments.

Eone Diagnomics Genome Center Co., Ltd.1 shared

EDGC, a Korea-US joint venture of Eone Medical Foundation and Diagnomics, offers the NIPT service NICE and liquid biopsy OncoCatch.

Precision Biosensor Inc.1 shared

KOSDAQ-listed IVD company producing time-resolved fluorescence immunodiagnostic products under the Exdia TRF brand.

RollingStone Co., Ltd.1 shared

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

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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