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祥生医疗全线产品斩获欧盟MDR认证 加速拓展全球市场
Zheng Quan Ri Bao Wang· 2025-07-16 11:50
Group 1 - The core viewpoint of the article highlights that Wuxi Xiangsheng Medical Technology Co., Ltd. has successfully obtained the EU Medical Devices Regulation (MDR) certification for its entire range of digital color ultrasound diagnostic products, marking a significant achievement in aligning with international safety and quality standards [1][2] - The MDR certification serves as a "hard currency" for entering the EU market and provides strong international credibility for the company's expansion into potential markets in Asia-Pacific, the Middle East, and Latin America [1] - Xiangsheng Medical has established a comprehensive technological capability in ultrasound imaging, covering various aspects from core components to clinical applications, thereby creating differentiated advantages in portability, specialization, and intelligence [1][2] Group 2 - The company's products are already utilized in over 30% of tertiary hospitals in China and have been exported to more than 100 countries and regions globally, establishing solid strategic partnerships with renowned international medical device companies [2] - In the field of ultrasound AI diagnostics, Xiangsheng Medical has developed an intelligent standard framework that encompasses device research and development, image acquisition, and diagnostic decision-making, with its breast ultrasound analysis software receiving medical device registration approval in 2022 [2] - The company aims to enhance its global market penetration with the MDR certification as a new starting point, focusing on providing smarter, more precise, and more accessible ultrasound diagnostic services worldwide, thereby strengthening the "China Intelligent Manufacturing" brand in the high-end medical device sector [2]