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Medical DevicesKOSDAQ 206640710 approvals

Boditech Med Inc.

Official website

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

As of 2026-10-10, Boditech Med Inc. has 708 Korean MFDS device approvals, 2 US FDA clearances/approvals, 15 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 and listed on KOSDAQ in 2014, Boditech Med is a point-of-care testing (POCT) medical device company specializing in immunodiagnostic cartridges and instruments. It supplies diagnostic cartridges for major conditions including CRP, PCT, D-Dimer, Vitamin D, Infliximab, and Adalimumab, along with the ichroma/ichroma II/ichroma III and AFIAS-6/AFIAS-10 point-of-care instruments, and also develops and sells higher-value products such as ST2 (cardiac risk prediction), MxA/CRP (viral vs. bacterial infection differentiation), PENKID (acute kidney injury measurement), and TDM (therapeutic drug monitoring) tests for antibody therapeutics. It sells about 120 cartridge products in roughly 130 countries worldwide, and added COVID-19 antigen and saliva antigen test products following the 2020 pandemic.

Products & technology

  • CRP/PCT/D-Dimer/Vitamin D/Infliximab/Adalimumab cartridgesImmunodiagnostic cartridges for major disease diagnosis
  • ichroma / ichroma II / ichroma IIIPoint-of-care immunodiagnostic instrument
  • AFIAS-1/3/6/10Fully automated point-of-care immunodiagnostic instrument
  • ST2Cartridge for predicting cardiac disease risk
  • MxA/CRPCartridge distinguishing viral vs. bacterial infection
  • PENKIDCartridge for measuring acute kidney injury
  • TDM diagnostic productsTherapeutic drug monitoring for antibody therapeutics
  • COVID-19 antigen and saliva antigen test productsCOVID-19 antigen diagnosis

Regulatory approvals

data.go.kr · openFDA

708 Korean MFDS device approvals · 2002–2026 / 2 US FDA 510(k) · 2014–2017

  • 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 method2026-09-22
    Product approval · Class 3체외 제허 26-717 호
  • MFDSImmunoabsorbance analyzer2026-08-31
    Product approval · Class 1체외 제신 26-1066 호
  • MFDSReal-time gene amplificator, nucleic acid2026-08-03
    Product approval · Class 2체외 제인 26-4716 호
  • MFDSIVD reagents for endocrine hormone and peptide2026-08-03
    Product approval · Class 2체외 제인 26-4710 호
  • MFDSIVD reagents for general immune test2026-07-14
    Product approval · Class 2체외 제인 26-4648 호
  • MFDSOther reagents, class Ⅱ, for clinical immunology2026-07-14
    Product approval · Class 2체외 제인 26-4646 호
  • MFDSOther reagents, class Ⅱ, for clinical immunology2026-07-14
    Product approval · Class 2체외 제인 26-4643 호
  • MFDSSpectrophotometer for clinical use2026-06-24
    Product approval · Class 1체외 제신 26-778 호
  • MFDSIVD reagents for general immune test2026-06-23
    Product approval · Class 2체외 제인 26-4571 호
  • MFDSIVD reagents for inflammatory tests2026-06-16
    Product approval · Class 2체외 제인 26-4530 호
  • MFDSIVD reagents for fecal occult blood test2026-06-16
    Product approval · Class 2체외 제인 26-4529 호
  • MFDSOther Reagents, classⅡ, for clinical chemistry2026-05-26
    Product approval · Class 2체외 제인 26-4467 호
Show 68 more
  • MFDSIVD reagents for bone and mineral metabolite measurement test2026-05-14
    Product approval · Class 2체외 제인 26-4433 호
  • MFDSIVD reagents for urine chemistry2026-05-08
    Product approval · Class 2체외 제인 26-4415 호
  • MFDSIVD reagents for diabetes mellitus2026-05-08
    Product approval · Class 2체외 제인 26-4410 호
  • MFDSOther Reagents, classⅡ, for clinical chemistry2026-05-04
    Product approval · Class 2체외 제인 26-4394 호
  • MFDSIVD reagents for urine chemistry2026-04-30
    Product approval · Class 2체외 제인 26-4388 호
  • MFDSCapillary blood collection tube2026-04-13
    Product approval · Class 1제신 26-437 호
  • MFDSIVD Reagents for pregnancy/childbirth hormone and protein tests2026-04-06
    Product approval · Class 2체외 제인 26-4305 호
  • MFDSIVD reagents for diabetes mellitus2026-04-06
    Product approval · Class 2체외 수인 26-4236 호
  • MFDSIVD reagents for inflammatory tests2026-03-18
    Product approval · Class 2체외 제인 26-4251 호
  • MFDSIVD reagents for fecal occult blood testRevoked2026-03-13
    Product approval · Class 2체외 제인 26-4234 호
  • MFDSIVD Reagents for pregnancy/childbirth hormone and protein tests2026-03-13
    Product approval · Class 2체외 제인 26-4233 호
  • MFDSIVD reagents for diabetes mellitus2026-03-10
    Product approval · Class 2체외 제인 26-4209 호
  • MFDSIVD reagents for electrolyte tests2026-03-06
    Product approval · Class 2체외 제인 26-4198 호
  • MFDSIVD reagents for toxin, heavy metal and drugs of abuse2026-03-05
    Product approval · Class 2체외 제인 26-4194 호
  • MFDSIVD reagents for toxin, heavy metal and drugs of abuse2026-03-05
    Product approval · Class 2체외 제인 26-4193 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 method2026-03-04
    Product approval · Class 3체외 제허 26-168 호
  • MFDSIVD reagents for toxin, heavy metal and drugs of abuse2026-03-04
    Product approval · Class 2체외 제인 26-4192 호
  • MFDSIVD reagents for diabetes mellitus2026-02-24
    Product approval · Class 2체외 제인 26-4162 호
  • MFDSIVD reagents for tumor marker2026-02-11
    Product approval · Class 3체외 제허 26-137 호
  • MFDSreagents for clinical enzymes2026-02-05
    Product approval · Class 2체외 제인 26-4119 호
  • MFDSreagents for clinical enzymes2026-02-05
    Product approval · Class 2체외 제인 26-4118 호
  • MFDSHematology analyzer, glycohemoglobin2026-01-26
    Product approval · Class 1체외 수신 26-213 호
  • MFDSHematology analyzer, glycohemoglobin2026-01-26
    Product approval · Class 1체외 수신 26-209 호
  • MFDSFluorimetric immunoassay analyzer(FIA), stationary2026-01-22
    Product approval · Class 1체외 제신 26-93 호
  • MFDSIVD reagents for general immune test2026-01-16
    Product approval · Class 2체외 제인 26-4047 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 method2026-01-02
    Product approval · Class 3체외 제허 26-4 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 method2026-01-02
    Product approval · Class 3체외 제허 26-3 호
  • MFDSIVD reagents for general immune test2025-12-17
    Product approval · Class 2체외 제인 25-5175 호
  • MFDSIVD reagents for inflammatory tests2025-12-17
    Product approval · Class 2체외 제인 25-5173 호
  • MFDSHemoglobin analyzer2025-12-08
    Product approval · Class 1체외 제신 25-1613 호
  • MFDSUrine chemistry analyzer, (semi-)automated2025-12-02
    Product approval · Class 1체외 제신 25-1588 호
  • MFDSHematology analyzer, cell-quantifying2025-11-18
    Product approval · Class 1체외 제신 25-1520 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 method2025-11-18
    Product approval · Class 3체외 제허 25-777 호
  • MFDSIVD Reagents for pregnancy/childbirth hormone and protein tests2025-11-05
    Product approval · Class 2체외 제인 25-5025 호
  • MFDSIVD Reagents for pregnancy/childbirth hormone and protein tests2025-11-04
    Product approval · Class 2체외 제인 25-5020 호
  • MFDSIVD reagents for inflammatory tests2025-10-31
    Product approval · Class 2체외 제인 25-5011 호
  • MFDSIVD Reagents for pregnancy/childbirth hormone and protein tests2025-10-27
    Product approval · Class 2체외 제인 25-4992 호
  • MFDSIVD Reagents for pregnancy/childbirth hormone and protein tests2025-10-27
    Product approval · Class 2체외 제인 25-4991 호
  • MFDSCentrifugal clinical chemistry automated analyser2025-10-20
    Product approval · Class 1체외 제신 25-1375 호
  • MFDSIVD Reagents for pregnancy/childbirth hormone and protein tests2025-10-17
    Product approval · Class 2체외 제인 25-4963 호
  • MFDSIVD reagents for diabetes mellitus2025-10-16
    Product approval · Class 2체외 제인 25-4961 호
  • MFDSIVD Reagents for pregnancy/childbirth hormone and protein tests2025-10-16
    Product approval · Class 2체외 제인 25-4958 호
  • MFDSIVD reagents for inflammatory tests2025-10-16
    Product approval · Class 2체외 제인 25-4954 호
  • MFDSIVD Reagents for pregnancy/childbirth hormone and protein tests2025-10-15
    Product approval · Class 2체외 제인 25-4948 호
  • MFDSIVD reagents for infectious inflammatory tests2025-10-02
    Product approval · Class 2체외 제인 25-4925 호
  • MFDSIVD reagents for cardiac marker2025-09-30
    Product approval · Class 3체외 제허 25-672 호
  • MFDSFluorimetric immunoassay analyzer(FIA), stationary2025-09-29
    Product approval · Class 1체외 제신 25-1293 호
  • MFDSIVD reagents for vitamin tests2025-09-29
    Product approval · Class 2체외 제인 25-4912 호
  • MFDSIVD Reagents for pregnancy/childbirth hormone and protein tests2025-09-29
    Product approval · Class 2체외 제인 25-4911 호
  • MFDSIVD reagents for anemia test2025-09-29
    Product approval · Class 2체외 제인 25-4910 호
  • MFDSIVD reagents for bone and mineral metabolite measurement test2025-09-29
    Product approval · Class 2체외 제인 25-4909 호
  • MFDSCentrifugal clinical chemistry automated analyserRevoked2025-09-26
    Product approval · Class 1체외 수신 25-2121 호
  • MFDSIVD Reagents for thyroid function hormone tests2025-08-27
    Product approval · Class 2체외 제인 25-4797 호
  • MFDSIVD Reagents for thyroid function hormone tests2025-08-27
    Product approval · Class 2체외 제인 25-4796 호
  • MFDSIVD Reagents for thyroid function hormone tests2025-08-27
    Product approval · Class 2체외 제인 25-4795 호
  • MFDSIVD Reagents for thyroid function hormone tests2025-08-26
    Product approval · Class 2체외 제인 25-4790 호
  • MFDSIVD Reagents for thyroid function hormone tests2025-08-26
    Product approval · Class 2체외 제인 25-4789 호
  • MFDSIVD reagents for cardiac marker2025-08-22
    Product approval · Class 3체외 제허 25-578 호
  • MFDSFluorimetric immunoassay analyzer(FIA), stationary2025-08-18
    Product approval · Class 1체외 제신 25-1064 호
  • MFDSClinical IVD strip for endocrine, related to pregnant2025-08-12
    Product approval · Class 2체외 제인 25-4753 호
  • MFDSClinical IVD strip for endocrine, related to pregnant2025-08-08
    Product approval · Class 2체외 제인 25-4732 호
  • MFDSIVD reagents for bone and mineral metabolite measurement test2025-07-08
    Product approval · Class 2체외 제인 25-4608 호
  • MFDSIVD reagents for inflammatory tests2025-06-27
    Product approval · Class 2체외 제인 25-4574 호
  • MFDSIVD reagents for diabetes mellitus2025-06-27
    Product approval · Class 2체외 제인 25-4573 호
  • MFDSIVD reagents for general immune test2025-04-28
    Product approval · Class 2체외 제인 25-4355 호
  • MFDSOther reagent of sample preparation kit2025-04-07
    Product approval · Class 1체외 제신 25-435 호
  • MFDSIVD reagents for diabetes mellitus2025-04-04
    Product approval · Class 2체외 제인 25-4286 호
  • MFDSIVD Reagents for pregnancy/childbirth hormone and protein testsRevoked2025-04-02
    Product approval · Class 2체외 제인 25-4268 호

Showing the 80 most recent of 710 records.

Key disclosures

KRX KIND via OpenDART

Publications

PubMed · affiliation-matched
Show 5 more publications

Patents

KIPRIS · applicant-matched
Show 242 more patents

AI reads

MAA server logs · IP-verified
184
Times AI engines pulled Boditech Med Inc.'s records

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Last 7 days
147
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Last 30 days
184
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  • OpenAIOAI-SearchBot152
  • GoogleGoogleOther18
  • PerplexityPerplexityBot7
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Measured since Aug 27, 2026 · 5 AI engines · last read Oct 9, 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.

SD BIOSENSOR INC.41 shared

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

GC Medical Science Corporation36 shared

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

DONG-A ST CO.,LTD30 shared

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

OSANG HEALTHCARE CO.,LTD.29 shared

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

Sugentech, Inc.25 shared

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

HUMASIS CO., LTD.24 shared

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

Access Bio, Inc.24 shared

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

NanoenTek,Inc.23 shared

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

Precision Biosensor Inc.20 shared

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

AHN-GOOK PHARMACEUTICAL Co., Ltd.19 shared

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

GENEMATRIX INC.19 shared

KOSDAQ-listed biotech company developing molecular diagnostics with proprietary C-Tag technology and the NeoPlex product line.

CALTH. Inc18 shared

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

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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