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Medical DevicesKOSDAQ 253840158 approvals

Sugentech, Inc.

Official website

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

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Market cap

Business overview

Source: DART corporate disclosure

Founded in 2011 and listed on KOSDAQ in 2019, Sugentech is an in-vitro diagnostics company spanning multiplex immunoblot, point-of-care testing (POCT), and digital healthcare. It offers the SGTi-Allergy Screen PLUS, which tests for 120 allergens, the SGTi-ANA Screen 14S autoimmune reagent with its fully automated S-Blot 3 system, the SGTi-flex COVID-19 Ag rapid antigen kit, the INCLIX quantitative diagnostic device for cardiovascular disease, diabetes, and hormones, and pregnancy, ovulation, and hormone test kits under its Surearly women's health brand. It holds multiple registered patents, including an automated analysis system (KR 10-2175186), a specimen tube holder (KR 10-1999604), a strip lot management process (KR 10-2241251), and a time-resolved fluorescence signal analyzer (KR 10-2126694).

Products & technology

  • SGTi-Allergy Screen (PLUS/60)Testing for up to 120 allergens
  • SGTi-ANA Screen 14SAutoimmune disease (ANA) diagnosis
  • S-Blot series (S-Blot 2/2 Easy/2 PLUS, S-Blot 3/3 PLUS, Tenfly Auto)Semi- and fully automated multiplex immunoblot analysis systems
  • SGTi-flex series (COVID-19 Ag, Influenza A&B, Dengue, Mycoplasma, etc.)Rapid antigen testing for infectious diseases
  • INCLIX / INCLIX F-100Quantitative diagnosis of cardiovascular disease, diabetes, and hormones (TRF fluorescence-based)
  • Surearly test kits and smart devicesHome testing for pregnancy, ovulation, menopause, and hormones
  • Hormone-personalized cosmetics and health functional foodsDiagnostic-data-based health and beauty solutions

Regulatory approvals

data.go.kr · openFDA

157 Korean MFDS device approvals · 2007–2026 / 1 US FDA 510(k) · 2016

  • MFDSClinical IVD strip for endocrine, related to pregnant2026-01-07
    Product approval · Class 2체외 제인 26-4015 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 method2025-12-15
    Product approval · Class 3체외 제허 25-840 호
  • MFDSIVD Reagents for pregnancy/childbirth hormone and protein tests2025-12-01
    Product approval · Class 2체외 제인 25-5116 호
  • MFDSIVD Reagents for pregnancy/childbirth hormone and protein tests2025-11-19
    Product approval · Class 2체외 제인 25-5074 호
  • MFDSIVD reagents for bone and mineral metabolite measurement test2025-10-27
    Product approval · Class 2체외 제인 25-4989 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 method2025-09-17
    Product approval · Class 3체외 제허 25-647 호
  • MFDSIVD Reagents for thyroid function hormone tests2025-09-09
    Product approval · Class 2체외 제인 25-4850 호
  • MFDSIVD Reagents for thyroid function hormone tests2025-07-08
    Product approval · Class 2체외 제인 25-4604 호
  • MFDSIVD reagents for allergy test2025-05-20
    Product approval · Class 2체외 제인 25-4431 호
  • MFDSIVD strip for endocrine self test2025-04-30
    Product approval · Class 2체외 제인 25-4366 호
  • MFDSIVD Reagents for thyroid function hormone tests2025-04-30
    Product approval · Class 2체외 제인 25-4365 호
  • MFDSIVD Reagents for thyroid function hormone tests2025-04-30
    Product approval · Class 2체외 제인 25-4364 호
Show 68 more
  • MFDSIVD strip for endocrine self test2024-12-31
    Product approval · Class 2체외 제인 24-1199 호
  • MFDSGeneral gene amplificator, nucleic acid, without fluorescence meter2024-12-24
    Product approval · Class 1체외 제신 24-1625 호
  • MFDSIVD reagents for diagnostic blood coagulation test2024-11-19
    Product approval · Class 3체외 제허 24-815 호
  • MFDSIVD Reagents for thyroid function hormone testsRevoked2024-11-01
    Product approval · Class 2체외 제인 24-984 호
  • MFDSIVD Reagents for pregnancy/childbirth hormone and protein tests2024-10-31
    Product approval · Class 2체외 제인 24-979 호
  • MFDSIVD reagents for inflammatory tests2024-10-29
    Product approval · Class 2체외 제인 24-972 호
  • MFDSIVD reagents for diabetes mellitus2024-10-25
    Product approval · Class 2체외 제인 24-965 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 method2024-10-21
    Product approval · Class 3체외 제허 24-709 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 method2024-10-17
    Product approval · Class 3체외 제허 24-703 호
  • MFDSIVD strip for endocrine self test2024-10-08
    Product approval · Class 2체외 제인 24-917 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 method2024-09-23
    Product approval · Class 3체외 제허 24-647 호
  • MFDSImmunoabsorbance analyzer2024-07-22
    Product approval · Class 1체외 제신 24-923 호
  • MFDSIVD reagents for urine chemistry2024-07-03
    Product approval · Class 2체외 제인 24-664 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 method2024-07-03
    Product approval · Class 3체외 제허 24-450 호
  • MFDSIVD reagents for allergy test2024-06-07
    Product approval · Class 2체외 제인 24-569 호
  • MFDSIVD strip for endocrine self test2024-04-18
    Product approval · Class 2체외 제인 24-403 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 method2024-04-08
    Product approval · Class 3체외 제허 24-248 호
  • MFDSIVD reagents for inflammatory tests2024-01-30
    Product approval · Class 2체외 제인 24-116 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 method2024-01-24
    Product approval · Class 3체외 제허 24-62 호
  • MFDSIVD reagents for allergy test2024-01-09
    Product approval · Class 2체외 제인 24-33 호
  • MFDSIVD reagents for diabetes mellitus2024-01-04
    Product approval · Class 2체외 제인 24-16 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 method2023-12-13
    Product approval · Class 3체외 제허 23-1133 호
  • MFDSImmunoabsorbance analyzer2023-12-06
    Product approval · Class 1체외 제신 23-1729 호
  • MFDSIVD reagents for allergy test2023-11-20
    Product approval · Class 2체외 제인 23-5263 호
  • MFDSEndocrinology/hormone analyzer for self test, related to pregnancy2023-10-10
    Product approval · Class 2체외 제인 23-5146 호
  • MFDSImmunoabsorbance analyzer2023-09-08
    Product approval · Class 1체외 제신 23-1355 호
  • MFDSImmunoabsorbance analyzer2023-06-19
    Product approval · Class 1체외 제신 23-942 호
  • MFDSIVD reagents for inflammatory testsRevoked2023-06-09
    Product approval · Class 2체외 제인 23-4795 호
  • MFDSIVD reagents for cardiac marker2023-05-08
    Product approval · Class 3체외 제허 23-565 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 23-510 호
  • MFDSIVD reagents for allergy test2023-03-31
    Product approval · Class 2체외 제인 23-4601 호
  • MFDSIVD strip for endocrine self test2023-03-24
    Product approval · Class 2체외 제인 23-4586 호
  • MFDSIVD strip for endocrine self test2023-03-24
    Product approval · Class 2체외 제인 23-4584 호
  • MFDSIVD strip for endocrine self test2023-03-24
    Product approval · Class 2체외 제인 23-4583 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 method2023-02-06
    Product approval · Class 3체외 제허 23-86 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 methodRevoked2022-12-05
    Product approval · Class 3체외 제허 22-822 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 method2022-12-05
    Product approval · Class 3체외 제허 22-820 호
  • MFDSIVD strip for endocrine self test2022-11-03
    Product approval · Class 2체외 제인 22-4841 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 method2022-09-29
    Product approval · Class 3체외 제허 22-652 호
  • MFDSImmunoabsorbance analyzer2022-09-06
    Product approval · Class 1체외 제신 22-1251 호
  • MFDSFluorimetric immunoassay analyzer(FIA), stationary2022-06-24
    Product approval · Class 1체외 제신 22-866 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 method2022-06-10
    Product approval · Class 3체외 제허 22-377 호
  • MFDSIVD reagents for autoimmune disease2022-03-11
    Product approval · Class 2체외 제인 22-4191 호
  • MFDSImmunoabsorbance analyzer2022-02-24
    Product approval · Class 1체외 제신 22-259 호
  • MFDSIVD reagent for infectious disease, immunological method2022-02-04
    Product approval · Class 3체외 제허 22-73 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 method2021-12-06
    Product approval · Class 3체외 제허 21-978 호
  • MFDSIVD reagents for autoimmune disease2021-10-28
    Product approval · Class 2체외 제인 21-4918 호
  • MFDSIVD strip for endocrine self test2021-06-29
    Product approval · Class 2체외 제인 21-4559 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 method2021-06-09
    Product approval · Class 3체외 제허 21-465 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 method2021-06-08
    Product approval · Class 3체외 제허 21-452 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 method2021-05-25
    Product approval · Class 3체외 제허 21-407 호
  • MFDSIVD reagents for diagnostic blood coagulation test2021-05-14
    Product approval · Class 3체외 제허 21-379 호
  • MFDSIVD strip for endocrine self test2021-04-21
    Product approval · Class 2체외 제인 21-4327 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 method2021-04-16
    Product approval · Class 3체외 제허 21-303 호
  • MFDSIVD strip for endocrine self test2021-01-27
    Product approval · Class 2체외 제인 21-4053 호
  • MFDSEndocrinology/hormone analyzer for self test, related to pregnancy2020-12-21
    Product approval · Class 2체외 제인 20-5127 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 method2020-12-18
    Product approval · Class 3체외 제허 20-1112 호
  • MFDSGeneral Calibrators, controls or standards, classⅢ, for clinical immunology, not a component of specific kit, wide use2020-12-16
    Product approval · Class 3체외 제허 20-1095 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 method2020-10-29
    Product approval · Class 3체외 제허 20-920 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 method2020-08-18
    Product approval · Class 3체외 제허 20-675 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 method2020-08-14
    Product approval · Class 3체외 제허 20-664 호
  • MFDSTool for specimens2020-08-13
    Product approval · Class 1수신 20-1928 호
  • MFDSImmunoabsorbance analyzer2020-07-16
    Product approval · Class 1체외 제신 20-1085 호
  • MFDSIVD reagents for allergy test2020-06-29
    Product approval · Class 2체외 제인 20-4571 호
  • MFDSFluorimetric immunoassay analyzer(FIA), stationary2020-06-26
    Product approval · Class 1체외 제신 20-977 호
  • MFDSCapillary blood collection tube2020-04-10
    Product approval · Class 1제신 20-503 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 method2020-03-24
    Product approval · Class 3체외 제허 20-215 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 method2020-03-24
    Product approval · Class 3체외 제허 20-214 호

Showing the 80 most recent of 158 records.

R&D and key agreements

Source: DART corporate disclosure

다중면역블롯 자동분석시스템 특허 · 등록/출원 · Holds patents for an automated analysis system (KR 10-2175186), strip temperature control (application 10-2021-0193129), specimen tube holder (KR 10-1999604), and strip lot management process (KR 10-2241251)

INCLIX 시간분해형광 분석기술 · 등록 · Holds a patent for a time-resolved fluorescence signal analyzer (KR 10-2126694)

Not yet compiled: business overview. Send us materials and we will add them

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 Corporation24 shared

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

OSANG HEALTHCARE CO.,LTD.21 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.

HUMASIS CO., LTD.17 shared

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

Precision Biosensor Inc.16 shared

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

PROTIA INC.13 shared

KOSDAQ-listed in-vitro diagnostics company selling PROTIA Allergy-Q allergy diagnostic products domestically and in 80+ countries.

CALTH. Inc12 shared

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

GENEMATRIX INC.11 shared

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

PCL. Inc11 shared

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

Micro Digital Co., Ltd.9 shared

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

Sources and updates

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

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