上海联影医疗科技股份有限公司关于取得医疗器械注册证的自愿性信息披露公告

Core Viewpoint - Shanghai United Imaging Healthcare Co., Ltd. has achieved significant milestones in obtaining medical device registrations, enhancing its competitive edge in the global market [1][2]. Group 1: Company Achievements - As of the end of Q1 2025, the company has registered products in over 80 countries and regions globally, with more than 140 products approved for market launch [1]. - The company has received FDA certification for 49 products and CE certification for another 49 products, including the complete uMI Panorama series [1]. - The uMR Jupiter is noted as the only full-body clinical ultra-high-field MRI system globally with NMPA, FDA, and CE approvals [1]. Group 2: Product Development and Market Strategy - The company has launched strategic innovative products in 2024, including the uLinac HalosTx precision radiotherapy system, uMR Max next-generation 3.0T MRI, and uAngio AVIVA intelligent suspension DSA [1]. - The acquisition of medical device registrations is expected to diversify the company's product offerings and meet varied clinical needs, thereby strengthening its core competitiveness [2]. - The company is developing products tailored to the specific needs of different countries and regions, facilitating the expansion of its product types available for sale internationally [2].