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Medical DevicesKOSDAQ 205470153 approvals
HUMASIS CO., LTD.
KOSDAQ-listed IVD company producing COVID-19 and HIV point-of-care diagnostic reagents alongside rubber products and entertainment businesses.
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Business overview
Source: DART corporate disclosureFounded in 2014 and listed on KOSDAQ in 2014, Humasis is a point-of-care (POCT) in-vitro diagnostics company. It produces POCT immunoassay reagents including COVID-19 and professional-use HIV diagnostic products, while subsidiary Billions produces rubber products such as male condoms, quasi-drugs, masks, and filters, and also operates an entertainment business managing actors and singers and producing dramas, films, and music content. The company develops and produces its own antigens as key raw materials for its diagnostic reagents and continues clinical research to improve the performance of existing diagnostic products.
Products & technology
- POCT immunoassay reagent (COVID-19)COVID-19 in-vitro diagnostics
- POCT immunoassay reagent (professional-use HIV)professional-use HIV in-vitro diagnostics
- male condoms and other rubber productsquasi-drugs, masks, filters
Regulatory approvals
data.go.kr153 Korean MFDS device approvals · 2009–2026
- MFDSIVD reagents for self testing of Influenza virus or SARS-CoV-2 using immunological method2026-08-04Product approval · Class 3체외 제허 26-595 호
- MFDSIVD reagents for diagnosis of HIV, HBV, HCV, HTLV, immunological method2024-12-24Product approval · Class 4체외 제허 24-906 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 method2024-08-27Product approval · Class 3체외 제허 24-585 호
- MFDSGeneral Calibrators, controls or standards, classⅢ, for clinical immunology, not a component of specific kit, wide use2024-03-26Product approval · Class 3체외 제허 24-208 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 method2023-04-18Product approval · Class 3체외 제허 23-509 호
- MFDSCapillary blood collection tube2023-04-03Product approval · Class 1수신 23-864 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 diagnosticsRevoked2022-12-21Product approval · Class 3체외 제허 22-882 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 method2022-11-30Product approval · Class 3체외 제허 22-804 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 method2022-11-08Product approval · Class 3체외 제허 22-748 호
- MFDSIVD reagents for diagnosis of HIV, HBV, HCV, HTLV, immunological method2022-08-30Product approval · Class 4체외 제허 22-583 호
- MFDSIVD reagents for serotyping or patient monitoring of HIV, HBV, HCV, HTLV, immunological method2022-07-18Product approval · Class 3체외 제허 22-462 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 method2022-07-12Product approval · Class 3체외 제허 22-446 호
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- MFDSIVD reagents for fecal occult blood test2022-07-08Product approval · Class 2체외 제인 22-4516 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 diagnosticsRevoked2022-03-08Product approval · Class 3체외 제허 22-155 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 diagnosticsRevoked2022-02-09Product approval · Class 3체외 제허 22-83 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 method2021-08-12Product approval · Class 3체외 제허 21-683 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 methodRevoked2021-05-06Product approval · Class 3체외 제허 21-352 호
- MFDSIVD reagent for infectious disease, immunological method2021-04-23Product approval · Class 3체외 제허 21-321 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 method2021-04-21Product approval · Class 3체외 제허 21-314 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 method2021-03-18Product approval · Class 3체외 제허 21-201 호
- MFDSTool for specimens2020-10-05Product approval · Class 1수신 20-2328 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 method2020-09-22Product approval · Class 3체외 제허 20-827 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 method2020-09-08Product approval · Class 3체외 제허 20-789 호
- MFDSIVD reagents for inflammatory tests2020-08-14Product approval · Class 2체외 제인 20-4759 호
- MFDSIVD Reagents for pregnancy/childbirth hormone and protein tests2020-04-21Product approval · Class 2체외 제인 20-4295 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 method2020-03-27Product approval · Class 3체외 제허 20-226 호
- MFDSIVD reagents for general immune test2020-01-08Product approval · Class 2체외 제인 20-4017 호
- MFDSIVD reagents for diagnosis of HIV, HBV, HCV, HTLV, immunological method2019-07-15Product approval · Class 4체외 제허 19-454 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 method2019-05-01Product approval · Class 3체외 제허 19-275 호
- MFDSIVD Reagents for thyroid function hormone testsRevoked2019-03-13Product approval · Class 2체외 제인 19-4180 호
- MFDSreagents for clinical enzymes2019-03-05Product approval · Class 2체외 제인 19-4149 호
- MFDSIVD reagents for general immune testRevoked2019-01-28Product approval · Class 2체외 제인 19-4063 호
- MFDSIVD Reagents for pregnancy/childbirth hormone and protein tests2019-01-23Product approval · Class 2체외 제인 19-4057 호
- MFDSIVD reagents for diagnosis of HIV, HBV, HCV, HTLV, immunological method2018-09-28Product approval · Class 4체외 제허 18-653 호
- MFDSTool for specimens2018-09-07Product approval · Class 1수신 18-2008 호
- MFDSUrine chemistry analyzer, (semi-)automatedRevoked2018-05-25Product approval · Class 1체외 제신 18-648 호
- MFDSTool for specimens2017-11-29Product approval · Class 1수신 17-3427 호
- MFDSIVD reagents for diagnosis of HIV, HBV, HCV, HTLV, immunological methodRevoked2017-11-24Product approval · Class 4체외 제허 17-907 호
- MFDSIVD Reagents for pregnancy/childbirth hormone and protein tests2017-02-28Product approval · Class 2체외 제인 17-155 호
- MFDSIVD Reagents for pregnancy/childbirth hormone and protein tests2017-01-03Product approval · Class 2체외 제인 17-8 호
- MFDSIVD reagents for infectious inflammatory tests2017-01-03Product approval · Class 2체외 제인 17-12 호
- MFDSIVD strip for endocrine self test2016-12-16Product approval · Class 2체외 제인 16-964 호
- MFDSIVD reagents for diagnosis of HIV, HBV, HCV, HTLV, immunological method2016-11-15Product approval · Class 4체외 제허 16-851 호
- MFDSIVD reagents for diagnosis of HIV, HBV, HCV, HTLV, immunological method2016-10-11Product approval · Class 4체외 제허 16-746 호
- MFDSIVD Reagents for thyroid function hormone tests2016-08-16Product approval · Class 2체외 제인 16-614 호
- MFDSTool for specimens2016-05-19Product approval · Class 1수신 16-1313 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 method2015-11-20Product approval · Class 3체외 제허 15-1602 호
- MFDSGeneral calibrators, controls or standards, classⅠ, for clinical chemistryRevoked2015-11-19Product approval · Class 1체외 제신 15-430 호
- MFDSGeneral calibrators, controls or standards, classⅠ, for clinical chemistryRevoked2015-11-19Product approval · Class 1체외 제신 15-431 호
- MFDSGeneral calibrators, controls or standards, classⅠ, for clinical chemistryRevoked2015-11-19Product approval · Class 1체외 제신 15-432 호
- MFDSreagents for clinical enzymes2015-11-12Product approval · Class 2체외 제인 15-1575 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 method2015-10-23Product approval · Class 3체외 제허 15-1516 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 method2015-08-01Product approval · Class 3체외 제허 15-1255 호
- MFDSOther reagents, class Ⅱ, for clinical immunologyRevoked2015-07-09Product approval · Class 2체외 수허 15-1283 호
- MFDSIVD Reagents for thyroid function hormone testsRevoked2015-07-08Product approval · Class 2체외 제인 15-1113 호
- MFDSIVD reagents for infectious inflammatory testsRevoked2015-04-22Product approval · Class 2체외 제인 15-618 호
- MFDSIVD strip for endocrine self test2015-04-09Product approval · Class 2체외 제인 15-509 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 method2015-02-24Product approval · Class 3체외 제허 15-238 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 method2015-02-24Product approval · Class 3체외 제허 15-239 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 method2015-02-24Product approval · Class 3체외 제허 15-240 호
- MFDSIVD reagents for diagnostic blood coagulation test2015-01-19Product approval · Class 3체외 제허 15-74 호
- MFDSFluorimetric immunoassay analyzer(FIA), stationary2015-01-13Product approval · Class 1경인 체외 제신 15-30 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 methodRevoked2014-12-24Product approval · Class 3체외 제허 14-3231 호
- MFDSIVD strip for endocrine self test2014-12-19Product approval · Class 2체외 제인 14-3201 호
- MFDSIVD reagents for tumor markerRevoked2014-12-05Product approval · Class 3체외 제허 14-2818 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 method2014-12-03Product approval · Class 3체외 제허 14-2760 호
- MFDSIVD strip for endocrine self testRevoked2014-11-24Product approval · Class 2체외 제인 14-2412 호
- MFDSIVD strip for endocrine self test2014-11-21Product approval · Class 2체외 제인 14-2342 호
- MFDSIVD strip for endocrine self test2014-11-21Product approval · Class 2체외 제인 14-2343 호
- MFDSIVD strip for endocrine self test2014-11-21Product approval · Class 2체외 제인 14-2344 호
- MFDSIVD strip for endocrine self test2014-11-21Product approval · Class 2체외 제인 14-2345 호
- MFDSIVD reagents for fecal occult blood test2014-11-21Product approval · Class 2체외 제인 14-2346 호
- MFDSIVD Reagents for pregnancy/childbirth hormone and protein tests2014-11-21Product approval · Class 2체외 제인 14-2347 호
- MFDSIVD strip for endocrine self testRevoked2014-11-21Product approval · Class 2체외 제인 14-2348 호
- MFDSIVD strip for endocrine self test2014-11-21Product approval · Class 2체외 제인 14-2349 호
- MFDSIVD strip for endocrine self test2014-11-21Product approval · Class 2체외 제인 14-2350 호
- MFDSClinical IVD strip for protein/lipid strip2014-11-21Product approval · Class 2체외 제인 14-2351 호
- MFDSClinical IVD strip for protein/lipid strip2014-11-21Product approval · Class 2체외 제인 14-2352 호
- MFDSIVD strip for endocrine self test2014-11-21Product approval · Class 2체외 제인 14-2353 호
- MFDSIVD strip for endocrine self test2014-11-21Product approval · Class 2체외 제인 14-2354 호
Showing the 80 most recent of 153 records.
R&D and key agreements
Source: DART corporate disclosure항원 자체 개발·생산 및 진단제품 성능 개선 · 체외진단 시약 · 연구개발 진행중 · In-house development and production of antigens as key raw materials, with ongoing clinical research to improve existing COVID-19 and HIV diagnostic products
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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.25 shared
KOSPI-listed in-vitro diagnostics company known for the STANDARD Q antigen/antibody test kits.
Boditech Med Inc.24 shared
KOSDAQ-listed point-of-care immunodiagnostics company supplying diagnostic cartridges and the ichroma/AFIAS instrument series.
GC Medical Science Corporation22 shared
GC Medical Science Corporation, KOSDAQ-listed since 2014, operates diagnostic reagent, blood glucose, and hemodialysis solution businesses.
OSANG HEALTHCARE CO.,LTD.19 shared
Founded 1996, listed on KOSDAQ in 2024, OSANG HEALTHCARE develops and sells biochemistry, immunodiagnostic, and molecular IVD products.
NanoenTek,Inc.18 shared
Founded in 1987 and listed on KOSDAQ in 2000, NanoenTek develops Lab-On-a-Chip in-vitro diagnostic devices and life science instruments.
Sugentech, Inc.17 shared
Founded in 2011 and KOSDAQ-listed in 2019, Sugentech develops multiplex immunoblot, point-of-care, and digital healthcare diagnostics.
CALTH. Inc14 shared
Holds manufacturing approvals for 42 point-of-care diagnostic reagents and devices in the IVD market.
Precision Biosensor Inc.13 shared
KOSDAQ-listed IVD company producing time-resolved fluorescence immunodiagnostic products under the Exdia TRF brand.
GENEMATRIX INC.12 shared
KOSDAQ-listed biotech company developing molecular diagnostics with proprietary C-Tag technology and the NeoPlex product line.
PCL. Inc12 shared
KOSDAQ-listed IVD company using SG Cap™ multiplex diagnostic technology for infectious disease, cancer, and companion animal testing.
RollingStone Co., Ltd.8 shared
KOSDAQ-listed in-vitro diagnostics company developing the LabChip-based VERI-Q molecular diagnostic device series.
i-SENS, Inc.6 shared
Founded in 2000 and KOSDAQ-listed in 2013, i-SENS makes blood glucose monitors and point-of-care testing devices.
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- Korea Exchange · DART
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- Measured 2026-08-13
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