医疗器械注册获批
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港股异动 先瑞达医疗-B(06669)盘中涨超5% 近日微导管V-otter注册申请获批
Jin Rong Jie· 2025-12-11 03:57
消息面上,近日,先瑞达医疗-B发布公告,集团收到中国国家药品监督管理局对微导管V-otter的注册批 准。V-otter适用于外周和冠脉血管经皮介入手术中,到达预期血管部位后输注诊断性、栓塞性或治疗性 的材料。V-otter是一款应用在肝动脉化疗栓塞术(TACE)中的微导管,其采用大内腔设计,可有效避免术 中导管堵塞;产品提供直型、45°单弯及多弯曲三种头端塑形选择,可根据临床实际需求从容适配不同 角度的分支血管,从而实现精准、稳定地抵达靶血管,为后续操作做好准备。 本文源自:智通财经网 智通财经获悉,先瑞达医疗-B(06669)盘中涨超5%,截至发稿,涨3.25%,报13.01港元,成交额244.95 万港元。 ...
先瑞达医疗-B:微导管V-otter的注册申请获中国国家药品监督管理局批准
Zhi Tong Cai Jing· 2025-12-03 08:48
先瑞达医疗-B(06669)发布公告,于2025年12月1日,集团收到中国国家药品监督管理局对微导管V-otter 的注册批准。V-otter适用于外周和冠脉血管经皮介入手术中,到达预期血管部位后输注诊断性、栓塞性 或治疗性的材料。V-otter是一款应用在肝动脉化疗栓塞术(TACE)中的微导管,其采用大内腔设计,可有 效避免术中导管堵塞;产品提供直型、45°单弯及多弯曲三种头端塑形选择,可根据临床实际需求从容适 配不同角度的分支血管,从而实现精准、稳定地抵达靶血管,为后续操作做好准备。公司将适时在中国 开展营销活动。 ...
先瑞达医疗-B:冠脉整体交换型球囊扩张导管井翼 的注册申请获中国国家药品监督管理局批准
Zhi Tong Cai Jing· 2025-11-18 10:06
Core Viewpoint - The company received approval from the National Medical Products Administration of China for its coronary overall exchange balloon dilation catheter, enhancing its product portfolio in the cardiovascular medical device market [1] Product Approval - The approval is for the "井翼" balloon dilation catheter, which is designed for treating coronary artery stenosis and bypass graft stenosis [1] - The catheter features a diameter range of 2.0-5.0mm, suitable for post-stent dilation [1] Product Features - The "井翼" is a semi-compliant balloon dilation catheter that offers superior passability and pushability due to its smaller head diameter and optimized delivery system [1] - It effectively addresses complex lesions such as chronic total occlusions and severe calcifications, improving procedural efficiency and safety [1] Marketing Plans - The company plans to initiate marketing activities in China at an appropriate time following the approval [1]