来源：广东省药品监督管理局 tto 63 11 简体 | 繁体 开启无障碍 | 开启长者助手 首页 新闻动态 政务公开 政务服务 公众参与 科普曾传 清绮入 您 当前位置：首页 > 政务公开 > 许可信息公开 > 医疗器械 > 医疗器械质量管理体系规范考核 2025年11月医疗器械注册质量管理体系 发布时间：2025-12-24 09:29:59 | 受理号 | 企业名称 | 产品名称 | 生产地址 | 核查 | 结论日期 | | --- | --- | --- | --- | --- | --- | | | | | | 结论 | | | 广东威诺敦生 | | | | 整改 后通 | | | CQZ2501532 | 物医药科技有 限公司 | 医用臭氧治疗仪 | 佛山市顺德区乐从镇水藤村委会创富六路1号联东科创园8座101、201、301 | 过核 | 2025/11/3 | | | | | | 査 | | | 广东百生医疗 | | | | 整改 后通 | | | CQX2501755 器械股份有限 高频手术设备 | 公司 | | 江门市新会区福盛路11号 | 过核 | 2025/11/3 | | | | | ...

Core Viewpoint - Baolait's stock price reached 9.49 yuan as of July 31, 2025, reflecting a 1.06% increase from the previous trading day [1] Group 1: Company Overview - Baolait operates in the medical device industry, focusing on the research, production, and sales of medical monitoring equipment [1] - The company's product range includes patient monitors, electrocardiograms, and maternal and child monitoring devices [1] Group 2: Financial Performance - On the trading day, the transaction volume was 179,815 hands, with a transaction amount of 172 million yuan [1] - The net inflow of main funds was 4.4345 million yuan, accounting for 0.22% of the circulating market value [1] Group 3: Corporate Governance - The company announced a second extraordinary general meeting of shareholders to be held on August 1, 2025, to discuss several proposals, including increasing registered capital, amending the company’s articles of association, and electing a new board of directors [1] - Shareholders can participate in the voting process either in person or through online voting [1]

Group 1 - Multiple medical devices and diagnostic kits have passed the quality management system inspection and are set to be approved for market use by June 2025 [3][4][5][6][7][8] - Companies involved include Shenzhen Sogang Technology Co., Ltd., Shenzhen Puhui Medical Technology Co., Ltd., and Guangzhou Wanfu Biotechnology Co., Ltd., among others [3][4][5][6][7][8] - The products range from laser treatment devices to diagnostic kits for various medical conditions, indicating a diverse portfolio in the medical technology sector [3][4][5][6][7][8] Group 2 - The inspections are part of a regulatory framework established by the Guangdong Provincial Drug Administration to ensure the quality and safety of medical devices [8] - The approval process includes a thorough review of manufacturing practices and compliance with established standards [8] - The timeline for passing inspections and receiving approvals is critical for companies aiming to launch their products in the competitive medical device market [8]