UIH(SH:688271) Zheng Quan Zhi Xing·2025-06-20 10:51Core Viewpoint - Shanghai United Imaging Healthcare Co., Ltd. has announced the acquisition of medical device registration certificates in both domestic and major overseas markets, reflecting its strong market access capabilities and product competitiveness [1][2]. Group 1: Medical Device Registration - The company has obtained various medical device registration certificates, including a medical angiography X-ray machine and multiple MRI systems, with effective dates ranging from January 2025 to June 2025 [1]. - The company has achieved global registration coverage in over 80 countries and regions, with more than 140 products approved for market, including 51 products with FDA 510(k) certification and 52 products with EU CE marking [1]. Group 2: Product Development and Market Strategy - The company has developed products tailored to the specific needs of different countries and regions, enhancing its core competitiveness and expanding the types of products available for sale abroad [2]. - The successful registration of these medical devices is expected to enrich the company's product offerings and meet diverse clinical demands, although the actual sales impact remains uncertain [2]. Group 3: Key Product Achievements - The company has made significant breakthroughs in interventional imaging equipment, with its self-developed digital subtraction angiography system (DSA) uAngio AVIVA CX receiving FDA 510(k) certification, marking it as the first and only domestic DSA device approved for the U.S. market [1]. - The company plans to complete the EU CE certification process for this product by the third quarter of 2025, aiming to provide advanced solutions in the global interventional medicine field [1].