医疗器械研发与注册
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安杰思子公司获得医疗器械注册证
Zhi Tong Cai Jing· 2025-12-24 11:27
Core Viewpoint - The company Anjies (688581.SH) announced that its subsidiary Hang'an Medical Technology (Hangzhou) Co., Ltd. has received medical device registration certificates from the Zhejiang Provincial Drug Administration for several endoscopic products, enhancing its product line in the endoscopy field [1] Group 1 - The registered products include an electronic endoscope image processor, an upper gastrointestinal electronic endoscope, and a lower gastrointestinal electronic endoscope [1] - The acquisition of these medical device registration certificates enriches the company's product offerings in the endoscopy diagnosis and treatment sector, addressing diverse clinical needs [1] - This development is expected to improve the company's overall market competitiveness and positively impact its sustainable growth [1]
亚虹医药:APLD-2304申报欧洲医疗器械注册获接收
Zhi Tong Cai Jing· 2025-12-21 08:03
Core Viewpoint - The company, Yahuang Pharmaceutical (688176.SH), has submitted a medical device registration application for its product APLD-2304 to the EU Notified Body (BSI Group The Netherlands B.V.), which has been accepted, pending further review and approval for market launch [1] Group 1 - APLD-2304 is the world's first portable single-use blue light bladder endoscope developed for the diagnosis and follow-up monitoring of bladder cancer [1]
蓝帆医疗(002382.SZ):子公司冠状动脉刻痕球囊扩张导管获得中国NMPA注册
Ge Long Hui A P P· 2025-12-11 11:28
Core Viewpoint - Blue Sail Medical (002382.SZ) has received the medical device registration certificate from the National Medical Products Administration (NMPA) for its self-developed and produced Class III medical device, the "Coronary Scoring Balloon Dilatation Catheter" (branded as "Star Scar™") [1] Group 1: Product Features - The Star Scar™ catheter features a unique spiral-wound triangular scoring wire that allows for 360° efficient pressure-focused dilation [1] - It is the market's highest with four scoring wires, providing a larger scoring area and a rated burst pressure (RBP) of up to 20 atm, which offers a higher safety expansion margin [1] - The device excels in reducing the incidence of dissection and optimizing vascular preparation, particularly advantageous for complex lesions such as calcification [1] Group 2: Market Implications - The introduction of the Star Scar™ catheter provides a safer and more ideal option for coronary intervention treatments [1]
港股异动 | 沛嘉医疗-B(09996)涨超6% Taurus NXT系统注册申请获受理 董事长本月开始增持
智通财经网· 2025-12-08 02:15
Core Viewpoint - Peijia Medical-B (09996) experienced a significant increase of over 6%, currently trading at 5.89 HKD, with a transaction volume of 1.9895 million HKD, following the announcement of the acceptance of its TAVR system registration application by the National Medical Products Administration of China [1] Group 1: Company Developments - Peijia Medical announced the receipt of an acceptance notice for the registration application of its TaurusNXT® "non-glutaraldehyde cross-linked" transcatheter aortic valve replacement (TAVR) system [1] - The TaurusNXT® is a third-generation TAVR system developed in-house, utilizing patented non-glutaraldehyde biological tissue cross-linking technology aimed at enhancing the durability and biocompatibility of artificial aortic valves [1] Group 2: Executive Actions - The board of directors has been informed that Dr. Zhang Yi, the executive director, CEO, and chairman of the board, will begin purchasing company shares in the open market starting December 1, 2025, with a total investment not exceeding 15 million HKD [1] - Dr. Zhang's planned share acquisition reflects his recognition of the company's intrinsic value and his strong confidence in the company's development prospects and growth potential [1]
联影医疗:全资子公司取得彩色多普勒超声诊断系统医疗器械注册证
Xin Lang Cai Jing· 2025-11-12 09:44
Core Viewpoint - The announcement highlights that the wholly-owned subsidiary of the company, Wuhan United Imaging Healthcare Co., Ltd., received a Medical Device Registration Certificate for its color Doppler ultrasound diagnostic systems, indicating a significant advancement in its product offerings [1] Product Development - The newly certified color Doppler ultrasound diagnostic systems include the uSONIQUE Pulse series, uSONIQUE Genesis series, and uSONIQUE Venus series, showcasing the company's commitment to developing a comprehensive range of ultrasound products [1] - This product range covers ultra-high-end, high-end, mid-range, and economical market segments, indicating a strategic approach to cater to diverse customer needs [1] Application Versatility - The certified ultrasound systems are designed to support a wide array of applications across various medical departments, including general medicine, cardiology, obstetrics, vascular, intensive care, emergency, anesthesia, and bedside use [1]