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Medical DevicesKOSDAQ 206640708 approvals

Boditech Med Inc.

Official website

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

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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

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

  • 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
  • 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
Show 68 more
  • 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
  • MFDSChemiluminescence assay(CLIA) analyzer2025-03-18
    Product approval · Class 1체외 수신 25-520 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 diagnostics2025-03-05
    Product approval · Class 3체외 제허 25-131 호

Showing the 80 most recent of 708 records.

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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.39 shared

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

GC Medical Science Corporation35 shared

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

OSANG HEALTHCARE CO.,LTD.28 shared

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

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.

Sugentech, Inc.24 shared

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

NanoenTek,Inc.22 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.19 shared

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

GENEMATRIX INC.19 shared

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

CALTH. Inc17 shared

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

PCL. Inc16 shared

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

i-SENS, Inc.12 shared

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

RollingStone Co., Ltd.11 shared

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

Sources and updates

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

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