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Medical DevicesKOSDAQ 30509030 approvals

Micro Digital Co., Ltd.

Official website

KOSDAQ-listed bioprocess and biomedical company supplying the CELBIC single-use cell culture system and the DxBIC automated analysis system.

As of 2026-10-11, Micro Digital Co., Ltd. has 30 Korean MFDS device approvals on record (counted by the MAA Company Index from its own matching of public databases).

Price

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Market cap

Business overview

Source: DART corporate disclosure

Founded in 2002 and listed on KOSDAQ in 2019, Micro Digital is a total-solution supplier specializing in bioprocess and biomedical products. In its bioprocess segment it supplies the CELBIC single-use cell culture system, 3D Culture Bag, and THEBAG; in its biomedical segment it supplies the DxBIC, Nabi, Mobi, Lubi, Lumi, iSBS, and Ubi Series automated analysis systems. In 2025 revenue was KRW 12.8 billion, up 11.4% year-over-year, comprising biomedical KRW 6.03 billion (47.0%), bioprocess KRW 3.11 billion (31.1%), and other products/consumables KRW 2.82 billion (21.9%), with domestic sales of KRW 9.47 billion (73.7%) and exports of KRW 3.38 billion (26.3%), sold through about 60 partner companies across roughly 30 countries.

Products & technology

  • CELBICSingle-use cell culture system for biopharmaceutical manufacturing
  • 3D Culture BagSingle-use bag consumable for cell culture process
  • THEBAGSingle-use bag consumable for cell culture process
  • DxBIC / Nabi / Mobi / Lubi / Lumi / iSBS / Ubi SeriesAutomated absorbance/luminescence/fluorescence analysis systems for sample collection, dilution, mixing, and dispensing

Regulatory approvals

data.go.kr

30 Korean MFDS device approvals · 2013–2026

  • MFDSSpectrophotometer for clinical use2026-07-31
    Product approval · Class 1체외 제신 26-951 호
  • MFDSImmunoabsorbance analyzer2025-06-02
    Product approval · Class 1체외 제신 25-700 호
  • MFDSReal-time gene amplificator, nucleic acid2025-04-01
    Product approval · Class 2체외 제인 25-4262 호
  • MFDSChemiluminescence assay(CLIA) analyzer2024-07-11
    Product approval · Class 1체외 제신 24-875 호
  • MFDSChemiluminescence assay(CLIA) analyzer2024-05-07
    Product approval · Class 1체외 제신 24-547 호
  • MFDSExtractor, nucleic acid2023-12-14
    Product approval · Class 1체외 제신 23-1773 호
  • MFDSExtractor, nucleic acid2023-12-12
    Product approval · Class 1체외 제신 23-1761 호
  • MFDSIVD reagents for cardiac marker2023-06-20
    Product approval · Class 3체외 제허 23-685 호
  • MFDSIVD reagents for cardiac marker2023-05-16
    Product approval · Class 3체외 제허 23-583 호
  • MFDSIVD reagents for cardiac marker2023-04-21
    Product approval · Class 3체외 제허 23-521 호
  • MFDSIVD reagents for cardiac marker2023-03-10
    Product approval · Class 3체외 제허 23-305 호
  • MFDSIVD Reagents for pregnancy/childbirth hormone and protein tests2023-03-07
    Product approval · Class 2체외 제인 23-4309 호
Show 18 more
  • MFDSIVD reagents for cardiac marker2022-09-13
    Product approval · Class 3체외 제허 22-610 호
  • MFDSIVD Reagents for thyroid function hormone tests2022-06-17
    Product approval · Class 2체외 제인 22-4456 호
  • MFDSIVD reagents for tumor marker2022-03-02
    Product approval · Class 3체외 제허 22-140 호
  • MFDSIVD reagents for cardiac marker2022-02-07
    Product approval · Class 3체외 제허 22-76 호
  • MFDSIVD Reagents for pregnancy/childbirth hormone and protein tests2022-02-03
    Product approval · Class 2체외 제인 22-4070 호
  • MFDSIVD reagents for tumor marker2022-01-24
    Product approval · Class 3체외 제허 22-47 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), immunological method2021-12-28
    Product approval · Class 3체외 제허 21-1045 호
  • MFDSIVD reagents for tumor marker2021-12-28
    Product approval · Class 3체외 제허 21-1042 호
  • MFDSImmunoabsorbance analyzer2021-08-04
    Product approval · Class 1체외 제신 21-1067 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), immunological method2021-04-20
    Product approval · Class 3체외 제허 21-307 호
  • MFDSImmunoabsorbance analyzer2020-09-07
    Product approval · Class 1체외 제신 20-1361 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), immunological method2020-09-02
    Product approval · Class 3체외 제허 20-773 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), immunological method2020-08-19
    Product approval · Class 3체외 제허 20-678 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), immunological method2020-06-25
    Product approval · Class 3체외 제허 20-511 호
  • MFDSChemiluminescence assay(CLIA) analyzer2019-04-18
    Product approval · Class 1체외 제신 19-492 호
  • MFDSSpectrophotometer for clinical use2017-11-09
    Product approval · Class 1체외 제신 17-1292 호
  • MFDSImmunoabsorbance analyzer2015-11-05
    Product approval · Class 1체외 제신 15-349 호
  • MFDSCombination stimulator, class 2Revoked2013-09-24
    Product approval · Class 2체외 제허 13-1635 호

Key disclosures

KRX KIND via OpenDART
Show 2 more events

Patents

KIPRIS · applicant-matched
Show 74 more patents

AI reads

MAA server logs · IP-verified
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Times AI engines pulled Micro Digital Co., Ltd.'s records

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Direct AI-tool queries (MCP)

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Last 7 days
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Last 30 days
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Measured since Aug 27, 2026 · 4 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.

Boditech Med Inc.10 shared

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

Sugentech, Inc.9 shared

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

GC Medical Science Corporation9 shared

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

OSANG HEALTHCARE CO.,LTD.8 shared

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

SD BIOSENSOR INC.8 shared

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

Precision Biosensor Inc.7 shared

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

CALTH. Inc7 shared

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

DONG-A ST CO.,LTD7 shared

Dong-A ST, spun off from Dong-A Socio Holdings in 2013 and KOSPI-listed, makes prescription drugs like Growtropin, Stillen, and Bacchus.

NanoenTek,Inc.6 shared

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

AHN-GOOK PHARMACEUTICAL Co., Ltd.5 shared

Ahn-Gook Pharmaceutical sells the cough/expectorant drug Sinecuran and the eye-health supplement Tobicom.

HUMASIS CO., LTD.5 shared

KOSDAQ-listed IVD company producing COVID-19 and HIV point-of-care diagnostic reagents alongside rubber products and entertainment businesses.

PCL. Inc5 shared

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

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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