Views: 0 Author: Site Editor Publish Time: 2025-12-10 Origin: Site
On December 2, 2025, MicroPort Robotics Group announced that its independently developed "Dragonfly Eye" stereoscopic electronic laparoscope has successfully obtained EU CE certification. This breakthrough not only marks a critical step for China's high-end surgical robot systems entering the international market but also brings the core component suppliers hidden behind the equipment—precision endoscope camera module manufacturers—into the spotlight.
The CE certification obtained by MicroPort Robotics' "Dragonfly Eye" stereoscopic electronic laparoscope is a significant event in the internationalization process of China's high-end medical equipment.
As a "passport" for products entering the European market, CE certification review covers multiple dimensions, including product safety, performance stability, and clinical effectiveness. Passing this certification means the entire system of the product, including its core imaging unit, fully complies with the stringent requirements of the EU Medical Device Regulation.
For upstream camera module manufacturers in the supply chain, this is not only a client's success but also international recognition of China's precision optical and electronic manufacturing capabilities. As the "eyes" of the endoscope, the imaging quality, 3D accuracy, color reproduction, and stability during prolonged operation of the module directly determine the clarity of the surgical field and the precision of the surgeon's operation.
Core of 3D Imaging: The key to the "Dragonfly Eye's" stereoscopic vision lies in its high-performance binocular stereo vision camera module. Such modules typically consist of two micro-cameras aligned with precise optics, simulating human binocular vision to generate real-time surgical images with depth information, providing an immersive operating experience for surgeons.
Significance of the Technological Breakthrough: This certification indirectly proves that domestic high-end 3D endoscope camera modules can meet the苛刻 standards of the top-tier international medical market in terms of resolution, low latency, low-light performance, and anti-interference capability. This lays a foundation of technical trust for future direct collaboration between domestic module manufacturers and international medical device giants.
As core component suppliers, camera module manufacturers played an indispensable role in this success. Manufacturing medical-grade camera modules is an interdisciplinary precision engineering feat involving micro-optical design, CMOS sensor integration, medical-grade sealing processes, and rigorous biocompatibility testing.
The modules must maintain long-term stable operation after undergoing high-temperature, high-pressure sterilization (e.g., 134°C steam sterilization) and provide reliable imaging within the complex biochemical environment of the human body. Passing the CE certification is also a comprehensive test of the entire supply chain's quality management system.
Technology and Quality Thresholds: Unlike consumer electronics cameras, medical endoscope modules have extreme requirements for sterility, fog resistance, corrosion resistance, and electromagnetic compatibility (EMC). Manufacturers must establish complete production and control processes compliant with the ISO 13485 Medical Device Quality Management System.
Market Impact: MicroPort Robotics' success has created a demonstration effect for the upstream supply chain. It showcases to the global market that China possesses the complete high-end manufacturing capability spanning from core modules to complete systems. It is anticipated that this will attract more international medical device companies to consider sourcing from or co-developing products with Chinese module manufacturers, thereby altering the existing global supply chain landscape.
The success of the "Dragonfly Eye" is not an endpoint but the starting line for the next generation of technological competition. From the perspective of module manufacturers, the future R&D focus is clear.
Cutting-Edge Module Technology: The next generation of endoscope camera modules is developing towards being "smaller, clearer, and smarter." Chip integration technology (such as integrating AI processing units on CIS) will enable the modules themselves to possess basic AI functions like real-time lesion identification and bleeding warning, reducing the processing load on the main system and lowering latency.
Expected Market Expansion: With the further global adoption of laparoscopic surgery and decreasing costs of robot-assisted surgery, the demand for high-end 3D endoscopes will continue to grow. This not only presents opportunities for OEMs but also creates vast market space for the entire ecosystem upstream, including optical lenses, micro-sensors, and specialized packaging materials.
For the endoscope industry, the camera module has evolved from a "functional component" to the "core that defines product excellence." Following the news of MicroPort's "Dragonfly Eye" laparoscope receiving EU CE certification, industry peers are paying closer attention to the technical architecture of its 3D visual imaging system and supply chain information.
A technical director from an endoscope solutions company in Shenzhen commented on an industry forum: "This certification was like a stress test, proving that the entire Chinese manufacturing chain—from lenses and sensors to image processing—can consistently deliver internationally first-class products."
As the surgical robot industry enters a period of rapid development, this technological competition that began with a single precision camera is reshaping the industrial map of the global high-end medical device sector.
