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Medical DevicesKOSDAQ 036220453 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.

As of 2026-10-09, OSANG HEALTHCARE CO.,LTD. has 450 Korean MFDS device approvals, 3 US FDA clearances/approvals, 2 PubMed-indexed papers 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

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

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

  • MFDSIVD reagents for diabetes mellitus2026-10-02
    Product approval · Class 2체외 제인 26-4901 호
  • MFDSCholesterol analyzer, laboratory2026-09-23
    Product approval · Class 1체외 제신 26-1173 호
  • MFDSBlood glucose meter for self test2026-09-09
    Product approval · Class 3체외 제허 26-690 호
  • MFDSIVD strip for glucose self test2026-09-09
    Product approval · Class 3체외 제허 26-689 호
  • MFDSIVD strip for glucose self test2026-09-09
    Product approval · Class 3체외 제허 26-688 호
  • MFDSBlood glucose meter for self test2026-09-09
    Product approval · Class 3체외 제허 26-687 호
  • 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
Show 68 more
  • 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
  • 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

Showing the 80 most recent of 453 records.

Key disclosures

KRX KIND via OpenDART

Publications

PubMed · affiliation-matched

Patents

KIPRIS · applicant-matched
Show 259 more patents

AI reads

MAA server logs · IP-verified
159
Times AI engines pulled OSANG HEALTHCARE CO.,LTD.'s records

Pulled records become part of each AI's index and keep feeding its answers. When an AI cites from that index, nothing reaches our server — so actual citations are uncounted here and exceed this number.

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Fetched fresh mid-answer

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.

158
Index crawls

Collected as raw material for future answers.

0
Direct AI-tool queries (MCP)

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

8
live 0
Last 7 days
130
live 1
Last 30 days
159
live 1
All time
  • OpenAIChatGPT-Userlive1
  • OpenAIOAI-SearchBot129
  • GoogleGoogleOther22
  • PerplexityPerplexityBot4
  • AnthropicClaudeBot2
  • MicrosoftBingbot1

Measured since Aug 27, 2026 · 5 AI engines · last read Oct 9, 2026

User-agent strings can be forged, so we do not count them at face value. We count only requests matched against vendor-published IP ranges, or confirmed by forward-verified reverse DNS. MCP queries are actual calls to this index's tool endpoint.

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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.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.29 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.

Access Bio, Inc.19 shared

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

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.

RollingStone Co., Ltd.16 shared

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

CALTH. Inc16 shared

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

PCL. Inc14 shared

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

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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