Recently, three core interventional access products independently developed by CoreRay Medical have successfully obtained EU CE certification:
Zhipeng Single-use Interventional Microcatheter
Zhiguan Peripheral Vascular Microguide Wire
Ruishen Balloon Dilatation Catheter
This marks CoreRay’s first EU CE certification since its founding, signifying international authoritative recognition of its R&D capabilities and quality system, and laying a solid foundation for entering the European and global markets.
EU CE certification is a globally recognized gold standard for medical device safety and performance, serving as the mandatory passport to the EU and European Free Trade Area. With stringent requirements, it represents a global threshold of high standards, high value, and high trust, confirming that the products:
Meet the highest requirements of the EU Medical Device Regulation (MDR) in safety and performance.
Gain free circulation in 30+ EU/EEA countries.
Boost confidence among professional users and enhance global market recognition.
Support domestic bidding policies encouraging innovative devices with international accreditation.
Developed on CoreRay’s proprietary B-E-S-T platform, the three products are engineered for complex vascular lesions, delivering superior support, crossing ability, and precision:
Zhipeng Microcatheter: High torque & high flow, 1:1 torque control in tortuous vessels.
Zhiguan Microguide Wire: Nitinol core with core-to-tip design for excellent trackability and kink resistance.
Ruishen Balloon Dilatation Catheter: High-pressure non-compliant balloon with tapered tip for precise dilation.
With CE certification, CoreRay will compete globally with leading brands, exemplifying the strength of China’s medical device innovation going global.