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Medical DevicesKOSDAQ 039860119 approvals

NanoenTek,Inc.

Official website

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

As of 2026-10-10, NanoenTek,Inc. has 119 Korean MFDS device approvals, 17 PubMed-indexed papers on record (counted by the MAA Company Index from its own matching of public databases).

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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
Show 68 more
  • 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.

Key disclosures

KRX KIND via OpenDART

Publications

PubMed · affiliation-matched
Show 7 more publications

Patents

KIPRIS · applicant-matched
Show 117 more patents

AI reads

MAA server logs · IP-verified
194
Times AI engines pulled NanoenTek,Inc.'s records

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Last 7 days
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194
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Measured since Aug 27, 2026 · 5 AI engines · last read Oct 8, 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.

Boditech Med Inc.23 shared

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

GC Medical Science Corporation23 shared

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

SD BIOSENSOR INC.21 shared

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

DONG-A ST CO.,LTD20 shared

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

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.

Precision Biosensor Inc.12 shared

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

PCL. Inc12 shared

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

Access Bio, Inc.12 shared

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

GENEMATRIX INC.12 shared

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

CALTH. Inc12 shared

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

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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