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医疗器械海外认证
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微电生理:两项产品获欧盟MDR认证完善海外技术矩阵
Cai Jing Wang· 2026-02-10 06:09
Core Viewpoint - Microelectrophysiology has recently announced that its magnetic navigation ablation catheter and star-shaped high-density mapping catheter have obtained the EU Medical Device Regulation (MDR) certification, which will facilitate the company's entry into the European market and enhance its overseas revenue through high-value-added products [1] Group 1 - The certification will assist the company in expanding its overseas revenue scale [1] - The company aims to enhance its overseas "mapping + ablation" technology matrix [1]
启明医疗-B盘中涨超7% Cardiovalve系统正式递交欧洲CE MDR认证申请
Zhi Tong Cai Jing· 2025-12-29 06:50
Core Viewpoint - Qiming Medical has made significant progress in the European market with its Cardiovalve transcatheter tricuspid valve replacement system, having submitted all application materials for CE certification, marking a key step in market entry [1] Group 1: Stock Performance - Qiming Medical's stock rose over 7% during trading, with a current increase of 4.05%, priced at HKD 2.57, and a trading volume of HKD 4.8942 million [1] Group 2: Product Development - The Cardiovalve system has successfully completed a confirmatory clinical study involving 150 patients in Europe, with positive mid-term results presented at the London Heart Valve Intervention Meeting [1] - The positive data from the TARGET study has received recognition and praise from overseas research expert teams, indicating strong support for the product [1] Group 3: Strategic Positioning - The progression to CE certification for the Cardiovalve system enhances Qiming Medical's "four-valve integration" product strategy, further completing its treatment matrix for tricuspid valve therapy alongside its established aortic and pulmonary valve product lines [1]