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 Insights - A new Class III medical device, "absorbable surgical suture," developed by Hainan Baimaike Medical Technology Co., Ltd., has been approved for market release by the National Medical Products Administration (NMPA) [1] - This approval marks the seventh Class III medical device approved in Hainan this year, contributing to a total of 28 approved devices in the province [1] - The average annual approval rate for Class III medical devices in Hainan has doubled over the past three years [1] Industry Developments - The absorbable surgical suture is made from a copolymer material consisting of 75% glycolide and 25% caprolactone, designed for soft tissue suturing [1] - The provincial drug regulatory authority has implemented measures to support the research and registration of Class III medical devices, providing focused guidance and full tracking services [1] - Hainan has two batches of five products included in the NMPA's priority review pilot program, accounting for approximately 10% of the national total [1]

Group 1 - The core idea of the article highlights the successful completion of the B+ round financing by Nanjing Pulimeng Medical Technology Co., Ltd., led by Huatai Zijin Investment and XG Industrial Investment [1][8] - The founder Liu Ping, with a medical background, identified a gap in the medical device market during his postdoctoral research in the United States, which fueled his entrepreneurial ambition [3][5] - Pulimeng's first product, an absorbable surgical suture, was approved for market in July 2020, featuring a unique cutting process and design that significantly improves suturing effectiveness compared to traditional products [5][3] Group 2 - Over its nine years of establishment, Pulimeng has developed two key technology platforms for biodegradable polymer material preparation and personalized processing of biodegradable medical devices, resulting in over 20 self-developed products [5][7] - The company's flagship product, the absorbable knotless barbed suture, utilizes a special processing technique and has a degradation period of approximately 180 days, simplifying the suturing process and reducing surgery time [5][3] - In the aesthetic medicine sector, Pulimeng has launched a recombinant collagen dressing and completed clinical trials for its "童颜针" (youthful needle), with promising data on its PLLA microsphere particles [5][3] Group 3 - The industrialization base project of Pulimeng was selected as a major project in Jiangsu Province for 2024, which has been completed and is set to enhance the company's production capacity and technological innovation [7][8] - The company has undergone multiple financing rounds, including nearly 100 million yuan in A round financing in 2022 and close to 200 million yuan in B round financing in 2023, with the latest B+ round financing amount undisclosed [8][7]