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Medical DevicesKOSDAQ 036220447 approvals

OSANG HEALTHCARE CO.,LTD.

Official website

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

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Market cap

Business overview

Source: DART corporate disclosure

OSANG HEALTHCARE was founded in 1996 and listed on KOSDAQ in 2024 as an IVD firm. Biochemistry diagnostics includes glucose monitors, POCT HbA1c meters, and POCT cholesterol meters; immunodiagnostics includes SelexOn devices and COVID-19 self-test kits; molecular diagnostics uses PCR-based products. Subsidiary OSANG LLC handles US distribution; manages Brazil distributor OSANG DO BRASIL LIMITADA.

Products & technology

  • 자가혈당측정기
  • POCT HbA1c 측정기
  • POCT 콜레스테롤 측정기
  • SelexOn
  • 코로나19 자가진단키트

Regulatory approvals

data.go.kr · openFDA

444 Korean MFDS device approvals · 1990–2026 / 3 US FDA 510(k) · 2018–2021

  • MFDSIVD strip for glucose self test2026-08-13
    Product approval · Class 3체외 제허 26-619 호
  • MFDSIVD strip for glucose self test2026-08-13
    Product approval · Class 3체외 제허 26-618 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 diagnostics2026-08-06
    Product approval · Class 3체외 제허 26-598 호
  • MFDSLancet, manually-operated, single-use2026-07-15
    Product approval · Class 2수인 26-4480 호
  • MFDSBlood glucose meter for self test2026-07-15
    Product approval · Class 3체외 제허 26-548 호
  • MFDSBlood glucose meter for self test2026-07-15
    Product approval · Class 3체외 제허 26-547 호
  • MFDSIVD strip for glucose self test2026-07-15
    Product approval · Class 3체외 제허 26-546 호
  • MFDSIVD strip for glucose self test2026-07-15
    Product approval · Class 3체외 제허 26-545 호
  • MFDSIVD strip for glucose self test2026-07-14
    Product approval · Class 3체외 제허 26-543 호
  • MFDSBlood glucose meter for self test2026-07-14
    Product approval · Class 3체외 제허 26-542 호
  • MFDSBlood glucose meter for self test2026-07-14
    Product approval · Class 3체외 제허 26-541 호
  • MFDSBlood glucose meter for self test2026-07-10
    Product approval · Class 3체외 제허 26-535 호
Show 68 more
  • MFDSBlood glucose meter for self test2026-07-10
    Product approval · Class 3체외 제허 26-534 호
  • MFDSIVD strip for glucose self test2026-07-10
    Product approval · Class 3체외 제허 26-533 호
  • MFDSBlood collection unit, non-needle2026-07-10
    Product approval · Class 1수신 26-1526 호
  • MFDSIVD strip for glucose self test2026-06-29
    Product approval · Class 3체외 제허 26-494 호
  • MFDSBlood glucose meter for self test2026-06-29
    Product approval · Class 3체외 제허 26-492 호
  • MFDSIVD strip for glucose self test2026-06-29
    Product approval · Class 3체외 제허 26-491 호
  • MFDSBlood glucose meter for self test2026-06-29
    Product approval · Class 3체외 제허 26-490 호
  • MFDSClinical IVD strip for protein/lipid strip2026-06-26
    Product approval · Class 2체외 제인 26-4582 호
  • MFDSClinical IVD strip for glucose strip2026-06-26
    Product approval · Class 2체외 제인 26-4581 호
  • MFDSIVD strip for glucose self test2026-06-26
    Product approval · Class 3체외 제허 26-488 호
  • MFDSBlood glucose meter for self test2026-06-26
    Product approval · Class 3체외 제허 26-487 호
  • MFDSBlood glucose meter for self test2026-06-26
    Product approval · Class 3체외 제허 26-486 호
  • MFDSBlood glucose meter for self test2026-06-16
    Product approval · Class 3체외 제허 26-453 호
  • MFDSBlood glucose meter for self test2026-06-16
    Product approval · Class 3체외 제허 26-452 호
  • MFDSBlood glucose meter for self test2026-06-10
    Product approval · Class 3체외 제허 26-434 호
  • MFDSBlood glucose meter for self test2026-06-10
    Product approval · Class 3체외 제허 26-433 호
  • MFDSBlood glucose meter for self test2026-06-10
    Product approval · Class 3체외 제허 26-432 호
  • MFDSBlood glucose meter for self test2026-06-10
    Product approval · Class 3체외 제허 26-431 호
  • MFDSBlood glucose meter for self test2026-06-09
    Product approval · Class 3체외 제허 26-427 호
  • MFDSBlood glucose meter for self test2026-06-09
    Product approval · Class 3체외 제허 26-426 호
  • MFDSBlood glucose meter for self test2026-05-28
    Product approval · Class 3체외 제허 26-400 호
  • MFDSBlood glucose meter for self test2026-05-28
    Product approval · Class 3체외 제허 26-399 호
  • MFDSSpectrophotometer for clinical use2026-05-18
    Product approval · Class 1체외 제신 26-610 호
  • MFDSBlood glucose meter for self test2026-05-18
    Product approval · Class 3체외 제허 26-371 호
  • MFDSBlood glucose meter for self test2026-05-18
    Product approval · Class 3체외 제허 26-370 호
  • MFDSIVD strip for glucose self test2026-05-18
    Product approval · Class 3체외 제허 26-369 호
  • MFDSIVD reagents for diabetes mellitus2026-05-15
    Product approval · Class 2체외 제인 26-4434 호
  • MFDSBlood collection unit, non-needle2026-05-14
    Product approval · Class 1수신 26-1037 호
  • MFDSBlood glucose meter for self test2026-04-30
    Product approval · Class 3체외 제허 26-326 호
  • MFDSIVD reagents for diabetes mellitus2026-04-20
    Product approval · Class 2체외 제인 26-4341 호
  • MFDSIVD strip for glucose self test2026-04-17
    Product approval · Class 3체외 제허 26-293 호
  • MFDSBlood glucose meter for self test2026-04-17
    Product approval · Class 3체외 제허 26-292 호
  • MFDSHematology analyzer, glycohemoglobin2026-04-09
    Product approval · Class 1체외 제신 26-427 호
  • MFDSBlood glucose meter for self test2026-03-30
    Product approval · Class 3체외 제허 26-233 호
  • MFDSBlood glucose meter for self test2026-03-30
    Product approval · Class 3체외 제허 26-232 호
  • MFDSBlood glucose meter for self test2026-03-26
    Product approval · Class 3체외 제허 26-228 호
  • MFDSIVD strip for glucose self test2026-03-04
    Product approval · Class 3체외 제허 26-167 호
  • MFDSBlood glucose meter for self test2026-03-04
    Product approval · Class 3체외 제허 26-166 호
  • MFDSBlood glucose meter for self test2026-02-25
    Product approval · Class 3체외 제허 26-157 호
  • MFDSIVD strip for glucose self test2026-02-25
    Product approval · Class 3체외 제허 26-156 호
  • MFDSClinical IVD strip for glucose strip2026-01-27
    Product approval · Class 2체외 제인 26-4083 호
  • MFDSClinical IVD strip for glucose strip2026-01-15
    Product approval · Class 2체외 제인 26-4044 호
  • MFDSBlood glucose meter for self test2026-01-13
    Product approval · Class 3체외 제허 26-38 호
  • MFDSBlood glucose meter for self test2026-01-09
    Product approval · Class 3체외 제허 26-27 호
  • MFDSBlood glucose meter for self test2026-01-09
    Product approval · Class 3체외 제허 26-26 호
  • MFDSIVD strip for glucose self test2026-01-09
    Product approval · Class 3체외 제허 26-25 호
  • MFDSIVD strip for glucose self test2026-01-09
    Product approval · Class 3체외 제허 26-24 호
  • MFDSIVD strip for endocrine self test2025-12-15
    Product approval · Class 2체외 제인 25-5161 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 method2025-11-06
    Product approval · Class 3체외 제허 25-749 호
  • MFDSGlucose analyzer for clinical use2025-10-02
    Product approval · Class 1체외 제신 25-1328 호
  • MFDSBlood glucose meter for self test2025-09-23
    Product approval · Class 3체외 제허 25-659 호
  • MFDSClinical IVD strip for glucose strip2025-08-27
    Product approval · Class 2체외 제인 25-4799 호
  • MFDSCapillary blood collection tube2025-07-21
    Product approval · Class 1제신 25-932 호
  • MFDSGeneral calibrators, controls or standards, classⅢ, for clinical chemistry2025-07-04
    Product approval · Class 3체외 제허 25-442 호
  • MFDSClinical IVD strip for glucose strip2025-06-25
    Product approval · Class 2체외 제인 25-4561 호
  • MFDSHematology analyzer, glycohemoglobin2025-06-04
    Product approval · Class 1체외 제신 25-704 호
  • MFDSGlucose analyzer for clinical use2025-04-14
    Product approval · Class 1체외 제신 25-469 호
  • MFDSGlucose analyzer for clinical use2025-04-14
    Product approval · Class 1체외 제신 25-468 호
  • MFDSGlucose analyzer for clinical use2025-04-02
    Product approval · Class 1체외 제신 25-410 호
  • MFDSGlucose analyzer for clinical use2025-03-26
    Product approval · Class 1체외 제신 25-379 호
  • MFDSIVD reagents for diabetes mellitus2025-03-26
    Product approval · Class 2체외 제인 25-4240 호
  • MFDSClinical IVD strip for protein/lipid strip2025-02-13
    Product approval · Class 2체외 제인 25-4129 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 diagnostics2025-01-02
    Product approval · Class 3체외 제허 25-8 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 diagnostics2025-01-02
    Product approval · Class 3체외 제허 25-7 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 method2025-01-02
    Product approval · Class 3체외 제허 25-6 호
  • MFDSSpectrophotometer for clinical use2024-11-26
    Product approval · Class 1체외 제신 24-1474 호
  • MFDSIVD reagents for histocompatibility antigen, antibody not for transfusion or transplantation but for specific disease diagnosis, molecular diagnostics2024-11-13
    Product approval · Class 2체외 제인 24-1020 호
  • MFDSHematology analyzer, glycohemoglobin2024-11-12
    Product approval · Class 1체외 제신 24-1399 호

Showing the 80 most recent of 447 records.

Not yet compiled: business overview · R&D. 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.35 shared

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

GC Medical Science Corporation31 shared

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

Boditech Med Inc.28 shared

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

Sugentech, Inc.21 shared

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

HUMASIS CO., LTD.19 shared

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

i-SENS, Inc.18 shared

Founded in 2000 and KOSDAQ-listed in 2013, i-SENS makes blood glucose monitors and point-of-care testing devices.

NanoenTek,Inc.17 shared

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

Precision Biosensor Inc.17 shared

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

CALTH. Inc16 shared

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

RollingStone Co., Ltd.16 shared

KOSDAQ-listed in-vitro diagnostics company developing the LabChip-based VERI-Q molecular diagnostic device series.

PCL. Inc14 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

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

This page is compiled from public sources without the company's involvement. If anything is inaccurate or incomplete, please let us know. Materials provided by the company are labelled as such.

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