The journey of blood gas analysis dates back to 1954 in Denmark, where the world’s first blood gas analyzer was created in response to the poliomyelitis outbreak. It provided critical diagnostic indicators for children requiring artificial ventilation. Over the decades, blood gas analysis has evolved from manual processes to fully automated systems, reflecting a global maturation of the field.
In China, the development of blood gas diagnostics has seen remarkable progress. From a standing start, the country achieved a breakthrough in 2013 when an elite team led by Dr. Lin Chao developed China’s first arterial blood gas analyzer, marking a significant milestone in EDAN’s journey of exploration and innovation.
Dr. Lin Chao
Chief Scientist of EDAN
PhD in Chemistry, Princeton University
Postdoctoral Fellow in Biophysical Chemistry, Yale University
70+ Patents: Pioneering POC Blood Gas Technology
EDAN has harnessed global innovation resources to establish world-class R&D platforms and assemble a team of top-tier experts. This commitment to excellence culminated in the development of the i15 blood gas biochemical analyzer—a groundbreaking product that incorporates over 70 national and utility model patents. As China's first and a globally leading device in its class, the i15 exemplifies cutting-edge advancements, employing proprietary technologies such as microarray chips and microfluidics to redefine precision and efficiency in blood gas analysis.
2011
Established the "Shenzhen Rapid Blood Testing and Analysis Technology Engineering Laboratory"
2012
Took on the Shenzhen Innovation Commission's project "R&D of POCT Diagnostic Systems and Key Technologies for Industrialization Based on Chemical and Biochemical Sensors"
2015
Jointly established the "Guangdong Provincial Clinical Rapid Diagnosis of Major Diseases Biosensor Engineering Technology Research Center" with Nanfang Hospital of Southern Medical University
2017
Undertook the "Shenzhen Strategic Emerging Industries and Future Industries Project" for industrialization of the i15 blood gas and biochemical analyzer and its supporting reagents
5000 Meters: Global Recognition Through Quality
"Quality control must be rooted in field application"—a principle that has consistently guided EDAN's rigorous quality control system. To ensure the accuracy of the i15 blood gas analyzer in high-altitude and low-temperature environments, EDAN has conducted extensive field tests in some of the world's most challenging conditions.
In 2017, the i15's performance was evaluated at the People's Hospital of Ali Region in Tibet, located at altitudes of 4,000 to 5,000 meters, focusing on the impact of high altitude on reagent packs and test card packaging.
A year later, in 2018, additional testing was carried out in La Paz, Bolivia, also situated at altitudes of 4,000 to 5,000 meters, further validating the i15’s reliability in extreme conditions.
As early as 2001, Edan passed the ISO13485 system certification and subsequently obtained CE certification and FDA registration. To date, it has successively achieved product registration and certification in countries such as Brazil and Canada, maintaining a globally consistent high-quality standard.
National Professional Electromagnetic Compatibility (EMC) Laboratory
A third-party medical electronic equipment testing laboratory accredited by CNAS (China National Accreditation Service for Conformity Assessment) and CMA (China Metrology Certification)
Passed the Bio-Rad Global External Quality Assessment (EQAS)
Achieved 4 consecutive years in Bio-Rad EQAS, 8 consecutive years with full marks in external assessments, and gained NCCL independent blood gas grouping—marking a key milestone in breaking the import monopoly in domestic blood gas.
A National Brand Rising to the Challenge
In 2020, the i15 achieved remarkable growth, shipping over 500 units and 300,000 test cards in February alone. Meeting the UK’s stringent requirements, it joined the NHS supplier catalog and equipped public hospitals, including the renowned NHS Nightingale Hospital, the world's largest intensive care unit.
22,000+ Unit Shipments: Expanding Global Reach
With a commitment to high-quality standards, the i15 has been sold in over 140 countries and regions, delivering more than 22,000 units (including veterinary models) to domestic and international medical institutions. It has successfully penetrated European and American markets, earning a place in prestigious hospitals such as St. Thomas’ Hospital, a leading NHS teaching hospital in London; Hospital Materno Infantil, Bolivia’s largest children’s hospital; and Errikos Ntynan Hospital Center, a top-tier facility in Greece.
This global presence exemplifies Chinese innovation and global sharing. In 2023, EDAN’s IVD business achieved 355 million yuan in revenue, marking a 19.79% year-on-year growth and becoming the company’s fastest-growing business segment.
12 Million Test Cartridges: Scaling Production Capacity
EDAN has established a world-class supply chain platform to accelerate the transformation of innovative technologies. In 2018, the company launched a production base capable of manufacturing 5 million microfluidic cartridges annually. By 2022, the EDAN Phase II Project introduced automation across product lines, significantly expanding blood gas production capacity.
In 2023, shipments of blood gas consumables surpassed 8 million units, with plans underway to reach an annual production capacity of 12 million cartridges.
10 Years of Innovation: Advancing Step by Step
2014
National Key New Product
2017
China Patent Excellence Award
2021
Excellent Domestic Medical Equipment Product Catalog
2023
IVDR CE Certificate
In 2022, EDAN launched the i20, combining blood gas and CO-oximetry analysis, ushering in the era of domestic blood gas 2.0. Along with the fully automated analyzer i500, EDAN now offers a complete platform spanning POC and benchtop solutions.
Over the past decade, EDAN's journey in the blood gas field has mirrored the evolution of China's blood gas industry. As we move forward, let's embrace the next golden decade of blood gas together!