Partnering with Leading Pharmaceutical Companies! Huiyi Intelligence’s UDI Traceability System Covers Over 500 Medical Device Products.
Release time:2025-09-29
On June 5, 2025, Guangzhou Huiyi Intelligent Technology Co., Ltd. announced that its independently developed intelligent medical device UDI (Unique Device Identification) traceability system has successfully been deployed to serve 12 leading medical device companies nationwide, covering more than 500 types of medical devices—including syringes, infusion sets, monitors, ventilators, and others. This system helps these companies fully meet the compliance requirements set forth by the National Medical Products Administration regarding the implementation of UDI for medical devices, thereby accelerating the development of a robust medical device traceability system.
The UDI for medical devices serves as the product’s “electronic ID.” Through the UDI traceability system, it’s possible to track medical devices throughout their entire lifecycle—from manufacturing and distribution to use—thereby playing a crucial role in ensuring product quality and safety and enhancing regulatory efficiency. Huiyi Intelligence’s UDI traceability system is centered around automated coding and data collection devices such as the HYBX-400, paired with self-developed traceability management software, forming a comprehensive end-to-end solution that covers “coding—data collection—uploading—management.” Specifically, the HYBX-400 automated coding and data collection device employs high-precision laser marking technology, enabling clear and durable coding on medical devices and packaging made of various materials—including metal, plastic, and glass—with fast coding speeds and exceptional durability. The traceability management software supports seamless integration with the National Medical Products Administration’s UDI database, enterprise manufacturing execution systems (MES), and warehouse management systems (WMS), thereby achieving real-time data synchronization and sharing.
As of the end of May 2025, the system has been deployed on more than 30 production lines across 12 leading medical device companies, covering over 500 product types and accumulating more than 100 million uniquely coded products traceable through the system. From the perspective of enterprise application results, the implementation of the UDI tracing system has not only helped companies smoothly pass compliance inspections by the National Medical Products Administration but has also significantly improved the efficiency of quality control throughout the production process. As a result, the average rate of defective products has dropped by 18%, and the time required to query traceability information has been reduced from the original 30 minutes to less than one minute. Moving forward, Huiyi Intelligence will continue to optimize the functionality of the UDI tracing system and expand its applications to additional niche areas such as orthopedic implants and in vitro diagnostic reagents, providing more comprehensive technical support for the construction of a traceability system in the medical device industry.
Relevant information
4/F, Building A1,No.10 Xicheng Zhong Street, Huangpu District, Guangzhou ,China.(510700)
WeChat Official Account