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Medical DevicesKOSDAQ 039860119 approvals

NanoenTek,Inc.

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

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Products & technology

  • Lab-On-a-Chip (LOC) diagnostic platformIn-vitro diagnostic device for clinical screening such as cancer diagnosis and white/red blood cell counting
  • Life science instruments and consumablesCell-counting equipment and related consumables for life science experiments

Regulatory approvals

data.go.kr

119 Korean MFDS device approvals · 2001–2026

  • MFDSOther Reagents, classⅡ, for clinical chemistry2026-04-24
    Product approval · Class 2체외 제인 26-4365 호
  • MFDSOther Reagents, classⅡ, for clinical chemistry2026-04-21
    Product approval · Class 2체외 제인 26-4348 호
  • MFDSIVD Reagents for thyroid function hormone tests2025-11-12
    Product approval · Class 2체외 제인 25-5049 호
  • MFDSIVD Reagents for thyroid function hormone tests2024-10-15
    Product approval · Class 2체외 제인 24-941 호
  • MFDSFluorimetric immunoassay analyzer(FIA), stationary2024-04-29
    Product approval · Class 1체외 제신 24-530 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 method2023-03-16
    Product approval · Class 3체외 제허 23-425 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 method2023-03-13
    Product approval · Class 3체외 제허 23-341 호
  • MFDSIVD reagents for inflammatory tests2022-11-29
    Product approval · Class 2체외 제인 22-4926 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 method2022-10-19
    Product approval · Class 3체외 제허 22-702 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 method2022-01-24
    Product approval · Class 3체외 제허 22-48 호
  • MFDSGeneral Calibrators, controls or standards, classⅢ, for clinical immunology, not a component of specific kit, wide use2021-10-05
    Product approval · Class 3체외 제허 21-827 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 method2021-06-25
    Product approval · Class 3체외 제허 21-527 호
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  • MFDSGeneral Calibrators, controls or standards, classⅢ, for clinical immunology, not a component of specific kit, wide use2020-11-18
    Product approval · Class 3체외 제허 20-975 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 method2020-11-16
    Product approval · Class 3체외 제허 20-966 호
  • MFDSIVD reagents for inflammatory tests2020-10-06
    Product approval · Class 2체외 제인 20-4909 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 method2020-10-05
    Product approval · Class 3체외 제허 20-855 호
  • MFDSGeneral Calibrators, controls or standards, classⅢ, for clinical immunology, not a component of specific kit, wide use2020-10-05
    Product approval · Class 3체외 제허 20-854 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 method2020-09-09
    Product approval · Class 3체외 제허 20-791 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 method2020-08-28
    Product approval · Class 3체외 제허 20-759 호
  • MFDSGeneral Calibrators, controls or standards, classⅢ, for clinical immunology, not a component of specific kit, wide use2020-08-14
    Product approval · Class 3체외 제허 20-656 호
  • MFDSGeneral Calibrators, controls or standards, classⅢ, for clinical immunology, not a component of specific kit, wide use2020-08-14
    Product approval · Class 3체외 제허 20-655 호
  • MFDSGeneral Calibrators, controls or standards, classⅢ, for clinical immunology, not a component of specific kit, wide use2020-08-14
    Product approval · Class 3체외 제허 20-654 호
  • MFDSGeneral Calibrators, controls or standards, classⅡ, for clinical immunology, not a component of specific kit, wide use2020-08-03
    Product approval · Class 2체외 제인 20-4700 호
  • MFDSGeneral Calibrators, controls or standards, classⅡ, for clinical immunology, not a component of specific kit, wide use2020-08-03
    Product approval · Class 2체외 제인 20-4698 호
  • MFDSGeneral Calibrators, controls or standards, classⅡ, for clinical immunology, not a component of specific kit, wide use2020-08-03
    Product approval · Class 2체외 제인 20-4699 호
  • MFDSIVD reagents for flow cytometric test2020-07-22
    Product approval · Class 2체외 제인 20-4654 호
  • MFDSGeneral Calibrators, controls or standards, classⅢ, for clinical immunology, not a component of specific kit, wide use2020-06-30
    Product approval · Class 3체외 제허 20-525 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 diagnostics2020-06-10
    Product approval · Class 3체외 제허 20-461 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 method2020-04-20
    Product approval · Class 3체외 제허 20-296 호
  • MFDSHematology analyzer, cell-quantifying2020-03-19
    Product approval · Class 1체외 제신 20-360 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 method2020-02-18
    Product approval · Class 3체외 제허 20-129 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 method2020-02-06
    Product approval · Class 3체외 제허 20-97 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 method2020-02-06
    Product approval · Class 3체외 제허 20-96 호
  • MFDSIVD reagents for diagnosis of HIV, HBV, HCV, HTLV, immunological method2020-01-09
    Product approval · Class 4체외 제허 20-22 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 method2020-01-09
    Product approval · Class 3체외 제허 20-21 호
  • MFDSHematology analyzer, cell-quantifying2019-07-08
    Product approval · Class 1체외 제신 19-918 호
  • MFDSGeneral calibrators, controls or standards, classⅠ, for clinical chemistryRevoked2019-06-13
    Product approval · Class 1체외 제신 19-775 호
  • MFDSIVD reagents for diagnostic blood coagulation test2019-03-15
    Product approval · Class 3체외 제허 19-157 호
  • MFDSGeneral calibrators, controls or standards, classⅠ, for clinical chemistryRevoked2018-09-20
    Product approval · Class 1체외 제신 18-1266 호
  • MFDSHematology analyzer, cell-quantifyingRevoked2018-06-15
    Product approval · Class 1체외 제신 18-729 호
  • MFDSOther Reagents, classⅡ, for clinical chemistry2018-02-14
    Product approval · Class 2체외 제인 18-4123 호
  • MFDSIVD reagents for hematological stains2017-08-10
    Product approval · Class 1체외 제신 17-919 호
  • MFDSGeneral calibrators, controls or standards, classⅠ, for clinical chemistryRevoked2017-07-03
    Product approval · Class 1체외 제신 17-771 호
  • MFDSHematology analyzer, cell-quantifying2016-12-20
    Product approval · Class 1체외 제신 16-1493 호
  • MFDSTool for specimens2016-11-23
    Product approval · Class 1수신 16-2976 호
  • MFDSIVD reagents for extracting nucleic acids2016-11-02
    Product approval · Class 1체외 제신 16-1303 호
  • MFDSGeneral calibrators, controls or standards, classⅠ, for clinical chemistryRevoked2016-07-04
    Product approval · Class 1체외 제신 16-816 호
  • MFDSGeneral calibrators, controls or standards, classⅠ, for clinical chemistryRevoked2016-07-04
    Product approval · Class 1체외 제신 16-818 호
  • MFDSGeneral calibrators, controls or standards, classⅠ, for clinical chemistryRevoked2016-07-01
    Product approval · Class 1체외 제신 16-812 호
  • MFDSGeneral calibrators, controls or standards, classⅠ, for clinical chemistryRevoked2016-07-01
    Product approval · Class 1체외 제신 16-814 호
  • MFDSGeneral calibrators, controls or standards, classⅠ, for clinical chemistryRevoked2016-07-01
    Product approval · Class 1체외 제신 16-813 호
  • MFDSIVD reagents for general immune test2016-04-22
    Product approval · Class 2체외 제인 16-312 호
  • MFDSIVD reagents for general immune test2016-04-22
    Product approval · Class 2체외 제인 16-313 호
  • MFDSHematology analyzer, cell-quantifying2016-04-20
    Product approval · Class 1체외 제신 16-482 호
  • MFDSIVD reagents for flow cytometric testRevoked2016-04-15
    Product approval · Class 2체외 제허 16-297 호
  • MFDSIVD Reagents for thyroid function hormone tests2016-02-12
    Product approval · Class 2체외 제인 16-104 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 method2016-01-22
    Product approval · Class 3체외 제허 16-39 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 method2016-01-22
    Product approval · Class 3체외 제허 16-40 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 method2015-12-11
    Product approval · Class 3체외 제허 15-1667 호
  • MFDSIVD reagents for infectious inflammatory tests2015-11-12
    Product approval · Class 2체외 제인 15-1573 호
  • MFDSIVD Reagents for thyroid function hormone tests2015-11-12
    Product approval · Class 2체외 제인 15-1574 호
  • MFDSBlood sample preparation instruments, general2015-09-25
    Product approval · Class 1체외 제신 15-171 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 method2015-09-25
    Product approval · Class 3체외 제허 15-1441 호
  • MFDSDry type clinical chemistry automated analyzer2015-08-19
    Product approval · Class 1체외 제신 15-62 호
  • MFDSIVD reagents for diagnosis of HIV, HBV, HCV, HTLV, immunological method2015-07-27
    Product approval · Class 4체외 제허 15-1237 호
  • MFDSGeneral calibrators, controls or standards, classⅠ, for clinical chemistryRevoked2015-07-22
    Product approval · Class 1경인 체외 제신 15-394 호
  • MFDSIVD Reagents for pregnancy/childbirth hormone and protein tests2015-07-06
    Product approval · Class 2체외 제인 15-1084 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 method2015-05-06
    Product approval · Class 3체외 제허 15-689 호
  • MFDSFluorimetric immunoassay analyzer(FIA), stationary2015-04-16
    Product approval · Class 1경인 체외 제신 15-173 호
  • MFDSIVD reagents for neurosecretion functionRevoked2015-04-16
    Product approval · Class 2체외 제인 15-576 호
  • MFDSDry type clinical chemistry automated analyzerRevoked2015-04-14
    Product approval · Class 1경인 체외 제신 15-168 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 method2015-03-30
    Product approval · Class 3체외 제허 15-441 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 method2015-03-30
    Product approval · Class 3체외 제허 15-442 호
  • MFDSGeneral calibrators, controls or standards, classⅠ, for clinical chemistryRevoked2014-12-16
    Product approval · Class 1서울 체외 수신 14-3103 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 methodRevoked2014-12-15
    Product approval · Class 3체외 제허 14-3046 호
  • MFDSIVD reagents for tumor marker2014-11-27
    Product approval · Class 3체외 제허 14-2638 호
  • MFDSIVD reagents for cardiac markerRevoked2014-11-27
    Product approval · Class 3체외 제허 14-2639 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 method2014-11-24
    Product approval · Class 3체외 제허 14-2399 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 method2014-11-24
    Product approval · Class 3체외 제허 14-2400 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 method2014-11-24
    Product approval · Class 3체외 제허 14-2404 호

Showing the 80 most recent of 119 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.

GC Medical Science Corporation23 shared

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

Boditech Med Inc.22 shared

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

SD BIOSENSOR INC.20 shared

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

HUMASIS CO., LTD.18 shared

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

Sugentech, Inc.18 shared

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

OSANG HEALTHCARE CO.,LTD.17 shared

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

CALTH. Inc12 shared

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

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.

Precision Biosensor Inc.12 shared

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

PROTIA INC.8 shared

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

RollingStone Co., Ltd.7 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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