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Medical DevicesKOSDAQ 205470153 approvals

HUMASIS CO., LTD.

Official website

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

As of 2026-10-11, HUMASIS CO., LTD. has 153 Korean MFDS device approvals 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 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.kr

153 Korean MFDS device approvals · 2009–2026

  • MFDSIVD reagents for self testing of Influenza virus or SARS-CoV-2 using immunological method2026-08-04
    Product approval · Class 3체외 제허 26-595 호
  • MFDSIVD reagents for diagnosis of HIV, HBV, HCV, HTLV, immunological method2024-12-24
    Product 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 method2024-08-27
    Product approval · Class 3체외 제허 24-585 호
  • MFDSGeneral Calibrators, controls or standards, classⅢ, for clinical immunology, not a component of specific kit, wide use2024-03-26
    Product 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 method2023-04-18
    Product approval · Class 3체외 제허 23-509 호
  • MFDSCapillary blood collection tube2023-04-03
    Product 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 diagnosticsRevoked2022-12-21
    Product 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 method2022-11-30
    Product 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 method2022-11-08
    Product approval · Class 3체외 제허 22-748 호
  • MFDSIVD reagents for diagnosis of HIV, HBV, HCV, HTLV, immunological method2022-08-30
    Product approval · Class 4체외 제허 22-583 호
  • MFDSIVD reagents for serotyping or patient monitoring of HIV, HBV, HCV, HTLV, immunological method2022-07-18
    Product 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 method2022-07-12
    Product approval · Class 3체외 제허 22-446 호
Show 68 more
  • MFDSIVD reagents for fecal occult blood test2022-07-08
    Product 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 diagnosticsRevoked2022-03-08
    Product 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 diagnosticsRevoked2022-02-09
    Product 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 method2021-08-12
    Product 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 methodRevoked2021-05-06
    Product approval · Class 3체외 제허 21-352 호
  • MFDSIVD reagent for infectious disease, immunological method2021-04-23
    Product 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 method2021-04-21
    Product 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 method2021-03-18
    Product approval · Class 3체외 제허 21-201 호
  • MFDSTool for specimens2020-10-05
    Product 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 method2020-09-22
    Product 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 method2020-09-08
    Product approval · Class 3체외 제허 20-789 호
  • MFDSIVD reagents for inflammatory tests2020-08-14
    Product approval · Class 2체외 제인 20-4759 호
  • MFDSIVD Reagents for pregnancy/childbirth hormone and protein tests2020-04-21
    Product 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 method2020-03-27
    Product approval · Class 3체외 제허 20-226 호
  • MFDSIVD reagents for general immune test2020-01-08
    Product approval · Class 2체외 제인 20-4017 호
  • MFDSIVD reagents for diagnosis of HIV, HBV, HCV, HTLV, immunological method2019-07-15
    Product 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 method2019-05-01
    Product approval · Class 3체외 제허 19-275 호
  • MFDSIVD Reagents for thyroid function hormone testsRevoked2019-03-13
    Product approval · Class 2체외 제인 19-4180 호
  • MFDSreagents for clinical enzymes2019-03-05
    Product approval · Class 2체외 제인 19-4149 호
  • MFDSIVD reagents for general immune testRevoked2019-01-28
    Product approval · Class 2체외 제인 19-4063 호
  • MFDSIVD Reagents for pregnancy/childbirth hormone and protein tests2019-01-23
    Product approval · Class 2체외 제인 19-4057 호
  • MFDSIVD reagents for diagnosis of HIV, HBV, HCV, HTLV, immunological method2018-09-28
    Product approval · Class 4체외 제허 18-653 호
  • MFDSTool for specimens2018-09-07
    Product approval · Class 1수신 18-2008 호
  • MFDSUrine chemistry analyzer, (semi-)automatedRevoked2018-05-25
    Product approval · Class 1체외 제신 18-648 호
  • MFDSTool for specimens2017-11-29
    Product approval · Class 1수신 17-3427 호
  • MFDSIVD reagents for diagnosis of HIV, HBV, HCV, HTLV, immunological methodRevoked2017-11-24
    Product approval · Class 4체외 제허 17-907 호
  • MFDSIVD Reagents for pregnancy/childbirth hormone and protein tests2017-02-28
    Product approval · Class 2체외 제인 17-155 호
  • MFDSIVD Reagents for pregnancy/childbirth hormone and protein tests2017-01-03
    Product approval · Class 2체외 제인 17-8 호
  • MFDSIVD reagents for infectious inflammatory tests2017-01-03
    Product approval · Class 2체외 제인 17-12 호
  • MFDSIVD strip for endocrine self test2016-12-16
    Product approval · Class 2체외 제인 16-964 호
  • MFDSIVD reagents for diagnosis of HIV, HBV, HCV, HTLV, immunological method2016-11-15
    Product approval · Class 4체외 제허 16-851 호
  • MFDSIVD reagents for diagnosis of HIV, HBV, HCV, HTLV, immunological method2016-10-11
    Product approval · Class 4체외 제허 16-746 호
  • MFDSIVD Reagents for thyroid function hormone tests2016-08-16
    Product approval · Class 2체외 제인 16-614 호
  • MFDSTool for specimens2016-05-19
    Product 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 method2015-11-20
    Product approval · Class 3체외 제허 15-1602 호
  • MFDSGeneral calibrators, controls or standards, classⅠ, for clinical chemistryRevoked2015-11-19
    Product approval · Class 1체외 제신 15-430 호
  • MFDSGeneral calibrators, controls or standards, classⅠ, for clinical chemistryRevoked2015-11-19
    Product approval · Class 1체외 제신 15-431 호
  • MFDSGeneral calibrators, controls or standards, classⅠ, for clinical chemistryRevoked2015-11-19
    Product approval · Class 1체외 제신 15-432 호
  • MFDSreagents for clinical enzymes2015-11-12
    Product 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 method2015-10-23
    Product 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 method2015-08-01
    Product approval · Class 3체외 제허 15-1255 호
  • MFDSOther reagents, class Ⅱ, for clinical immunologyRevoked2015-07-09
    Product approval · Class 2체외 수허 15-1283 호
  • MFDSIVD Reagents for thyroid function hormone testsRevoked2015-07-08
    Product approval · Class 2체외 제인 15-1113 호
  • MFDSIVD reagents for infectious inflammatory testsRevoked2015-04-22
    Product approval · Class 2체외 제인 15-618 호
  • MFDSIVD strip for endocrine self test2015-04-09
    Product 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 method2015-02-24
    Product 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 method2015-02-24
    Product 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 method2015-02-24
    Product approval · Class 3체외 제허 15-240 호
  • MFDSIVD reagents for diagnostic blood coagulation test2015-01-19
    Product approval · Class 3체외 제허 15-74 호
  • MFDSFluorimetric immunoassay analyzer(FIA), stationary2015-01-13
    Product 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 methodRevoked2014-12-24
    Product approval · Class 3체외 제허 14-3231 호
  • MFDSIVD strip for endocrine self test2014-12-19
    Product approval · Class 2체외 제인 14-3201 호
  • MFDSIVD reagents for tumor markerRevoked2014-12-05
    Product 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 method2014-12-03
    Product approval · Class 3체외 제허 14-2760 호
  • MFDSIVD strip for endocrine self testRevoked2014-11-24
    Product approval · Class 2체외 제인 14-2412 호
  • MFDSIVD strip for endocrine self test2014-11-21
    Product approval · Class 2체외 제인 14-2342 호
  • MFDSIVD strip for endocrine self test2014-11-21
    Product approval · Class 2체외 제인 14-2343 호
  • MFDSIVD strip for endocrine self test2014-11-21
    Product approval · Class 2체외 제인 14-2344 호
  • MFDSIVD strip for endocrine self test2014-11-21
    Product approval · Class 2체외 제인 14-2345 호
  • MFDSIVD reagents for fecal occult blood test2014-11-21
    Product approval · Class 2체외 제인 14-2346 호
  • MFDSIVD Reagents for pregnancy/childbirth hormone and protein tests2014-11-21
    Product approval · Class 2체외 제인 14-2347 호
  • MFDSIVD strip for endocrine self testRevoked2014-11-21
    Product approval · Class 2체외 제인 14-2348 호
  • MFDSIVD strip for endocrine self test2014-11-21
    Product approval · Class 2체외 제인 14-2349 호
  • MFDSIVD strip for endocrine self test2014-11-21
    Product approval · Class 2체외 제인 14-2350 호
  • MFDSClinical IVD strip for protein/lipid strip2014-11-21
    Product approval · Class 2체외 제인 14-2351 호
  • MFDSClinical IVD strip for protein/lipid strip2014-11-21
    Product approval · Class 2체외 제인 14-2352 호
  • MFDSIVD strip for endocrine self test2014-11-21
    Product approval · Class 2체외 제인 14-2353 호
  • MFDSIVD strip for endocrine self test2014-11-21
    Product approval · Class 2체외 제인 14-2354 호

Showing the 80 most recent of 153 records.

R&D and key agreements

Source: DART corporate disclosure

항원 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

Key disclosures

KRX KIND via OpenDART
Show 2 more events

Patents

KIPRIS · applicant-matched
Show 5 more patents

AI reads

MAA server logs · IP-verified
128
Times AI engines pulled HUMASIS CO., LTD.'s records

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Times an AI needed something not yet in its index and fetched this page fresh while answering. Citations served from the index leave no trace here.

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Queries from users who connected this index to their own AI.

6
live 0
Last 7 days
107
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Last 30 days
128
live 2
All time
  • OpenAIChatGPT-Userlive2
  • OpenAIOAI-SearchBot104
  • GoogleGoogleOther14
  • PerplexityPerplexityBot6
  • AnthropicClaudeBot2

Measured since Aug 25, 2026 · 4 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.26 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.

DONG-A ST CO.,LTD16 shared

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

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.

Access Bio, Inc.13 shared

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

PCL. Inc12 shared

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

GENEMATRIX INC.12 shared

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

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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