Information
132 Anyangcheondong-ro, Dongan-gu, Anyang, Gyeonggi-do, South Korea
+82 31-460-0401
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Overview
- Summary
- OSANG Healthcare is an in-vitro diagnostics (IVD) specialist company dedicated to developing blood diagnostic biosensors, developing, manufacturing, and selling medical devices in biochemical, immunoassay, and molecular diagnostics, including blood glucose, HbA1c, and cholesterol measuring biosensors, as well as COVID-19 and flu co-diagnosis kits. The company aims to realize 'Technology for Everyone' by making medical equipment home-friendly and enabling simple measurement of all diseases. It exports products to over 110 countries worldwide, solidifying its position in the global healthcare market. OSANG Healthcare is a leading South Korean company committed to improving health and quality of life by providing advanced medical devices and innovative healthcare solutions.OSANG Healthcare is an in-vitro diagnostics (IVD) specialist company dedicated to developing blood diagnostic biosensors, developing, manufacturing, and selling medical devices in biochemical, immunoassay, and molecular diagnostics, including blood glucose, HbA1c, and cholesterol measuring biosensors, as well as COVID-19 and flu co-diagnosis kits. The company aims to realize 'Technology for Everyone' by making medical equipment home-friendly and enabling simple measurement of all diseases. It exports products to over 110 countries worldwide, solidifying its position in the global healthcare market. OSANG Healthcare is a leading South Korean company committed to improving health and quality of life by providing advanced medical devices and innovative healthcare solutions.
- Key Products/Technologies
- **Biochemical Diagnostic Product Line**: Blood glucose meters (GluNEO, GluNEO H, Oh'Care Lite, etc.), HbA1c measuring biosensors (CLOVER A1c Plus, CLOVER A1c Expert, CLOVER A1c Self), and cholesterol measuring biosensors (LipidPro Meter, LipidPro HDL-Cholesterol Strip). Specifically, GluNEO H complies with international quality standards (ISO 15197:2013), capable of measuring both capillary and venous blood, and enhances accuracy by compensating for hematocrit influence. CLOVER A1c Plus is an enzyme-based HbA1c meter with a measurement range of NGSP 4-14% and IFCC 20-130 mmol/mol, providing results within 5 minutes.**Biochemical Diagnostic Product Line**: Blood glucose meters (GluNEO, GluNEO H, Oh'Care Lite, etc.), HbA1c measuring biosensors (CLOVER A1c Plus, CLOVER A1c Expert, CLOVER A1c Self), and cholesterol measuring biosensors (LipidPro Meter, LipidPro HDL-Cholesterol Strip). Specifically, GluNEO H complies with international quality standards (ISO 15197:2013), capable of measuring both capillary and venous blood, and enhances accuracy by compensating for hematocrit influence. CLOVER A1c Plus is an enzyme-based HbA1c meter with a measurement range of NGSP 4-14% and IFCC 20-130 mmol/mol, providing results within 5 minutes.
- **Immunoassay Diagnostic Product Line**: COVID-19 self-test kits (OHC COVID-19 Antigen Self Test), professional COVID-19/flu antigen co-diagnosis kits (GeneFinder COVID-19/Flu Antigen Professional Test), and personal COVID-19/flu combo kits. SelexOn is an immunoassay diagnostic product co-developed with the Korea Research Institute of Bioscience and Biotechnology. The COVID-19/flu combo kit is a diagnostic device capable of simultaneously identifying COVID-19 and Influenza A and B.**Immunoassay Diagnostic Product Line**: COVID-19 self-test kits (OHC COVID-19 Antigen Self Test), professional COVID-19/flu antigen co-diagnosis kits (GeneFinder COVID-19/Flu Antigen Professional Test), and personal COVID-19/flu combo kits. SelexOn is an immunoassay diagnostic product co-developed with the Korea Research Institute of Bioscience and Biotechnology. The COVID-19/flu combo kit is a diagnostic device capable of simultaneously identifying COVID-19 and Influenza A and B.
- **Molecular Diagnostic Product Line**: Infectious disease diagnostic products (excluding respiratory infection tests), HLA (Human Leukocyte Antigen) including endogenous factor test product line, and GeneFinder HLA-B*5801 Plus RealAmp Kit. The GeneFinder HLA-B*5801 Plus RealAmp Kit is a diagnostic kit for identifying gout patients at high risk of severe cutaneous adverse reactions (SCAR) induced by allopurinol. Investment in the US startup Kryptos Biotechnologies for the development of photothermal PCR-based point-of-care (POC) molecular diagnostic devices.**Molecular Diagnostic Product Line**: Infectious disease diagnostic products (excluding respiratory infection tests), HLA (Human Leukocyte Antigen) including endogenous factor test product line, and GeneFinder HLA-B*5801 Plus RealAmp Kit. The GeneFinder HLA-B*5801 Plus RealAmp Kit is a diagnostic kit for identifying gout patients at high risk of severe cutaneous adverse reactions (SCAR) induced by allopurinol. Investment in the US startup Kryptos Biotechnologies for the development of photothermal PCR-based point-of-care (POC) molecular diagnostic devices.
- **Continuous Glucose Monitoring (CGM)**: Investment in the US biotech venture Allez Health to develop CGM, specifically targeting the integrated continuous glucose monitoring system (ICGM) that integrates with insulin pumps. Development is underway with the goal of obtaining US FDA approval and market entry by 2026.**Continuous Glucose Monitoring (CGM)**: Investment in the US biotech venture Allez Health to develop CGM, specifically targeting the integrated continuous glucose monitoring system (ICGM) that integrates with insulin pumps. Development is underway with the goal of obtaining US FDA approval and market entry by 2026.
- Core Advantages
- **Diversified In-Vitro Diagnostic Portfolio**: As one of the few domestic IVD companies operating in biochemical, immunoassay, and molecular diagnostics, it has established product lineups across various disease diagnostic areas. This strength allows for flexible response to disease outbreaks and market changes.**Diversified In-Vitro Diagnostic Portfolio**: As one of the few domestic IVD companies operating in biochemical, immunoassay, and molecular diagnostics, it has established product lineups across various disease diagnostic areas. This strength allows for flexible response to disease outbreaks and market changes.
- **Global Market Competitiveness and Certifications**: The first Korean company to receive US FDA approval for personal blood glucose meters in 2003, and recently obtained European CE IVDR certification for personal blood glucose meters, affirming essential performance and safety for global market entry. High recognition in overseas markets through US FDA Emergency Use Authorization (EUA) and professional product approval for personal COVID-19/flu combo kits.**Global Market Competitiveness and Certifications**: The first Korean company to receive US FDA approval for personal blood glucose meters in 2003, and recently obtained European CE IVDR certification for personal blood glucose meters, affirming essential performance and safety for global market entry. High recognition in overseas markets through US FDA Emergency Use Authorization (EUA) and professional product approval for personal COVID-19/flu combo kits.
- **Continuous Research and Development and Innovation**: Leveraging over 20 years of accumulated technology and expertise for the development of high-performance personal blood glucose meters and proactive investment in next-generation diagnostic technologies like continuous glucose monitoring (CGM). Efforts to secure innovative technologies, including investment in a US startup for photothermal PCR-based point-of-care molecular diagnostic devices.**Continuous Research and Development and Innovation**: Leveraging over 20 years of accumulated technology and expertise for the development of high-performance personal blood glucose meters and proactive investment in next-generation diagnostic technologies like continuous glucose monitoring (CGM). Efforts to secure innovative technologies, including investment in a US startup for photothermal PCR-based point-of-care molecular diagnostic devices.
- **Strong Distribution Network and Partnerships**: During the COVID-19 pandemic, the company supplied personal COVID-19 self-test kits to pharmacies through Yuhan Corporation, and also supplies new blood glucose meter products to Yuhan Corporation via an ODM model, securing a nationwide pharmacy sales network. Capability to export to over 110 countries worldwide through its global distribution network.**Strong Distribution Network and Partnerships**: During the COVID-19 pandemic, the company supplied personal COVID-19 self-test kits to pharmacies through Yuhan Corporation, and also supplies new blood glucose meter products to Yuhan Corporation via an ODM model, securing a nationwide pharmacy sales network. Capability to export to over 110 countries worldwide through its global distribution network.
- **Excellence in Quality Management System**: International recognition of its systematic quality management system's excellence, evidenced by the fastest issuance of CE IVDR certification for personal blood glucose meters by the European notified body BSI.**Excellence in Quality Management System**: International recognition of its systematic quality management system's excellence, evidenced by the fastest issuance of CE IVDR certification for personal blood glucose meters by the European notified body BSI.
- Target Industrie
- **Medical and Healthcare Industry**: Disease diagnosis and monitoring in medical institutions such as hospitals, clinics, and public health centers. Individual self-health management and monitoring of chronic diseases (diabetes, hyperlipidemia, etc.).**Medical and Healthcare Industry**: Disease diagnosis and monitoring in medical institutions such as hospitals, clinics, and public health centers. Individual self-health management and monitoring of chronic diseases (diabetes, hyperlipidemia, etc.).
- **Research and Clinical Diagnostics**: Biochemical, immunoassay, and molecular diagnostic tests in research and clinical settings. Specifically, HbA1c meters are used by professionals in laboratories, hospitals, and clinics.**Research and Clinical Diagnostics**: Biochemical, immunoassay, and molecular diagnostic tests in research and clinical settings. Specifically, HbA1c meters are used by professionals in laboratories, hospitals, and clinics.
- Major Markets
- South Korea, JapanSouth Korea, Japan
- All European Union countriesAll European Union countries
- United StatesUnited States
- Certifications/Patents
- **US FDA Approval**: First Korean company to receive US FDA approval for personal blood glucose meters in 2003. US FDA Emergency Use Authorization (EUA) and professional product approval for personal COVID-19/flu combo kits. FDA Emergency Use Authorization for COVID-19 diagnostic kits (molecular diagnostic reagents).**US FDA Approval**: First Korean company to receive US FDA approval for personal blood glucose meters in 2003. US FDA Emergency Use Authorization (EUA) and professional product approval for personal COVID-19/flu combo kits. FDA Emergency Use Authorization for COVID-19 diagnostic kits (molecular diagnostic reagents).
- **European CE IVDR Certification**: Obtained European In Vitro Diagnostic Medical Device Regulation (IVDR) certification for personal blood glucose meters. Sequential IVDR certification planned for major products including HbA1c meters (biochemical diagnostics), rapid diagnostic kits (immunoassay diagnostics), and diagnostic reagents (molecular diagnostics).**European CE IVDR Certification**: Obtained European In Vitro Diagnostic Medical Device Regulation (IVDR) certification for personal blood glucose meters. Sequential IVDR certification planned for major products including HbA1c meters (biochemical diagnostics), rapid diagnostic kits (immunoassay diagnostics), and diagnostic reagents (molecular diagnostics).
- **International Quality Standards**: Personal blood glucose meter GluNEO H demonstrates excellent performance compliant with international quality standards (ISO 15197:2013).**International Quality Standards**: Personal blood glucose meter GluNEO H demonstrates excellent performance compliant with international quality standards (ISO 15197:2013).
- **Patents**: 42 patents related to blood glucose meters and biosensors. 30 patents including bead measurement methods. Technology protected by over 10 patents related to photothermal PCR-based point-of-care molecular diagnostic devices. Completed Freedom-to-Operate (FTO) analysis for continuous glucose monitoring (CGM) development.**Patents**: 42 patents related to blood glucose meters and biosensors. 30 patents including bead measurement methods. Technology protected by over 10 patents related to photothermal PCR-based point-of-care molecular diagnostic devices. Completed Freedom-to-Operate (FTO) analysis for continuous glucose monitoring (CGM) development.
- **Ministry of Food and Drug Safety (MFDS) Approval**: MFDS approval for the new personal blood glucose meter 'GluNEO H'. MFDS approval for 'GeneFinder HLA-B*5801 Plus RealAmp Kit'. MFDS approval for COVID-19 self-test kits.**Ministry of Food and Drug Safety (MFDS) Approval**: MFDS approval for the new personal blood glucose meter 'GluNEO H'. MFDS approval for 'GeneFinder HLA-B*5801 Plus RealAmp Kit'. MFDS approval for COVID-19 self-test kits.
Introduction
Location
132 Anyangcheondong-ro, Dongan-gu, Anyang, Gyeonggi-do, South Korea
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