Core technology support for sustainable innovation
Zecen Biotech Co., Ltd. has filed multiple invention patents in the preparation of magnetic microparticles and luminescent substrates, and holds independent intellectual property rights in the development of key product raw materials. The company currently holds more than 50 granted invention patents, with nearly 100 invention patent applications pending. It owns the intellectual property rights for the intelligent diagnostic system based on tube‑based magnetic particle chemiluminescence immunoassay, covering core steps such as magnetic bead conjugation, antibody labeling, and substrate synthesis.

Over 300 registered products with broad clinical applications
Zecen Biotech Co., Ltd. has obtained nearly 30 Class III registration certificates, over 200 Class II registration certificates, and nearly 50 Class I filings, with nearly 100 additional Class II and Class III applications currently under review. The assay menu covers cardiology, hormones, thyroid function, infectious diseases, tumor markers, glucose metabolism, bone metabolism, inflammation, women's & children’s health, and other areas, providing a comprehensive diagnostic basis for clinical testing.

300+ products certified for global market access
The company's independently developed instruments and supporting reagents, audited by TÜV, successfully obtained EU CE certification in 2017. To date, over 300 products have received CE certification, and the products have been successfully introduced into more than 30 countries and regions worldwide, including Europe, Southeast Asia, the Middle East, Africa, and Latin America.

Sustainable compliance with global quality standards
The company strictly adheres to the "Medical Device Production Quality Management Practices" and ISO 13485:2016 quality management system standards, having established and implemented a quality management system tailored to its product characteristics. Its independently developed instruments and supporting reagents, audited by TÜV, successfully obtained EU CE certification in 2017. At the end of 2018, the company obtained the ISO 13485 Medical Device Quality Management System certification, and has successfully passed annual surveillance audits every year since.