Core Viewpoint - The China Securities Regulatory Commission (CSRC) has requested additional documentation from Nanjing Puhui Medical regarding its overseas listing application, focusing on compliance with foreign investment regulations and the status of shareholder equity [1][2]. Group 1: Regulatory Requirements - CSRC has asked Nanjing Puhui Medical to clarify whether its business operations fall under the "Negative List" of foreign investment restrictions as per the 2024 version [2]. - The company must also disclose if the shares of shareholders participating in the "full circulation" are subject to any pledges, freezes, or other rights defects [2]. - Additional information is required regarding the company's previous A-share listing guidance and the reasons for the termination of its application to the Shenzhen Stock Exchange [2]. Group 2: Company Overview - Nanjing Puhui Medical specializes in X-ray imaging technology, expanding its product range to over 100 models, including mobile C-arm X-ray machines and digital radiography systems [2][3]. - The company is recognized as the first manufacturer in China to receive approval for an integrated solution combining orthopedic surgical robots and mobile 3D C-arms, enhancing its position in the market [3]. - The orthopedic surgical robot system market in China is projected to reach RMB 20.7 billion by 2032, indicating significant growth potential for the company [3]. Group 3: Production Capabilities - As of December 31, 2024, Nanjing Puhui Medical operates two production bases and employs a team of 130 staff [3]. - The Nanjing facility produces digital radiography systems, mobile C-arm X-ray machines, and orthopedic surgical robots, while the Zhuhai facility focuses on digital radiography systems and fluoroscopy machines [3].

智通财经APP获悉，据港交所4月30日披露，南京普爱医疗设备股份有限公司(普爱医疗)递表港交所，国泰君安国际为其独家保荐人。据招股书，于往绩记录 期间，普爱医疗的产品已销往中国所有省份，贡献超过70.0%的总收入，并出口至全球逾100个国家，贡献其余收入。根据灼识咨询的数据，按销售量计， 公司于2023年为中国第二大医用X射线成像系统供货商，市场份额为7.6%。 据普爱医疗招股书的风险因素部分所述，公司可能无法及时以可接受的成本成功完成产品注册检验或临床试验，甚或根本无法完成。 招股书显示，普爱医疗专注于X射线成像技术，从最初的一款产品起步，截至最后实际可行日期(2025年4月20日)，产品组合已扩展至逾100款型号，并以X 射线管组件、高压发生器及三维成像技术等专有技术为支撑。公司的产品组合涵盖：移动式C形臂X射线机，一种主要用于外科手术时可以移动的，具有C 形机架的X射线透视和摄影设备；数字化摄影X射线机(DR)，一种将X射线光子信号转换为数字图像的医用辐射成像设备；及DRF数字化透视摄影X射线 机，一种数字胃肠机。 招股书提到，于2022年6月，普爱医疗的骨科手术机器人加移动式三维C形臂一体化解决方案获 ...