【微电生理：公司磁导航消融导管及星型高密度标测导管获得欧盟MDR认证】智通财经2月9日电，微 电生理(688351.SH)公告称，公司磁导航消融导管及星型高密度标测导管于近日获得了欧盟医疗器械法 规（MDR）认证证书。这将助力公司进入欧洲市场，扩大海外收入规模，并完善了公司海外"标测+消 融"技术矩阵。然而，产品在国际市场销售可能会受到海外法规政策、市场环境变化、汇率波动等不确 定因素的影响，目前尚无法预测其对公司未来业务的具体影响。 转自：智通财经 ...

格隆汇2月9日｜微电生理公告，公司磁导航消融导管及星型高密度标测导管于近日获得了欧盟医疗器械 法规（TheMedicalDevice Regulations (EU) 2017/745，简称"MDR"）认证证书。 ...

（文章来源：证券日报） 证券日报网讯 2月2日，微电生理发布公告称，公司的产品一次性使用心腔内超声成像导管于近日获得 了国家药品监督管理局颁发的《中华人民共和国医疗器械注册证》。 ...

Group 1 - Far East Holdings announced that its subsidiary won a contract order worth 3.075 billion yuan, including contracts for green building cables and smart manufacturing cables [1] - Yifan Pharmaceutical received a drug registration certificate for Vitamin K1 injection, which is used to treat vitamin K deficiency-related bleeding [2] - Guangdong Electric Power A's Maoming Bohua Power Plant's Unit 4 has successfully commenced commercial operation, with a total investment of 7.484 billion yuan and an expected annual power generation of 8.6 billion kWh [4] Group 2 - Longfly Fiber reported that the global fiber optic cable industry market environment is normal, with product price fluctuations needing comprehensive assessment [25] - Shanghai Yizhong's net profit for 2025 increased by 819.42%, with total revenue of 317 million yuan, a growth of 82.72% [22] - Guizhou Power's subsidiary received a government subsidy of 200 million yuan [8] Group 3 - Zhongxing Communications plans to invest 117 million yuan in the Jianxing Zhanlu Fund, which focuses on new information technology and advanced manufacturing [10] - Suwen Electric Power's subsidiary established a joint investment fund with a total commitment of 68.5 million yuan, with Suwen contributing 5 million yuan [26] - ST Kaiyuan announced that its stock may face delisting risk due to expected negative net assets for 2025 [27]

微电生理(688351.SH)公告，公司产品一次性使用心腔内超声成像导管于近日获得了国家药品监督管理 局颁发的《医疗器械注册证》。 ...

智通财经APP讯，微电生理(688351.SH)公告，公司产品一次性使用心腔内超声成像导管于近日获得了 国家药品监督管理局颁发的《医疗器械注册证》。 ...

本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 证券代码：688351 证券简称：微电生理 公告编号：2026-002 上海微创电生理医疗科技股份有限公司（以下简称"公司"）的产品一次性 使用心腔内超声成像导管于近日获得了国家药品监督管理局颁发的《中华人民共 和国医疗器械注册证》，现将相关情况公告如下： 二、对公司的影响 公司本次获批的一次性使用心腔内超声成像导管与便携式数字化彩色超声 诊断仪配合使用，可用于心脏及心脏大血管、心内解剖结构的超声成像；与三维 心脏电生理标测系统配合使用时，可提供导管定位信息。同时，具备磁定位功能， 1 上海微创电生理医疗科技股份有限公司 关于取得医疗器械注册证的自愿披露公告 特此公告。 上海微创电生理医疗科技股份有限公司董事会 2026 年 2 月 3 日 2 注册人名称 上海微创电生理医疗科技股份有限公司 产品名称 一次性使用心腔内超声成像导管 注册证编号 国械注准 20263060230 有效期 2026 年 1 月 29 日至 2031 年 1 月 28 日 适用范围 本产品在医疗机构 ...

Core Viewpoint - The company has received the Medical Device Registration Certificate from the National Medical Products Administration for its disposable intracardiac ultrasound imaging catheter, indicating a significant regulatory milestone for the product [1] Product Details - The product is designed for use in medical institutions in conjunction with portable digital color ultrasound diagnostic devices for ultrasound imaging of the heart, major blood vessels, and intracardiac anatomical structures [1] - When used with a three-dimensional cardiac electrophysiology mapping system, the catheter provides catheter positioning information, enhancing procedural accuracy [1] - The catheter features magnetic positioning capabilities, allowing for simultaneous ultrasound imaging and catheter localization, which provides additional intraoperative information to physicians [1]

近日， 国家药品监督管理局（NMPA）批准了 慧扬医疗科技（苏州）有限公司 的 射频穿刺发生器 （ 国械注准20263010216 ）、 上海微创电生理医疗科 技股份有限公司 的 一次性使用心腔内超声成像导管 （ 国械注准20263060230 ）和 杭州微引科技有限公司 的 CT引导穿刺手术定位系统 （ 国械注准 20263010251 ） ， 3项创新医疗器械注册申请。 截至目前，我国上市的创新医疗器械累计达到 3 98 项 。 该产品由射频主机、脚踏开关及中性电极线组成，与一次性使用射频房间隔穿刺针配合使用，利用射频电流的热效应用于右心房至左心房的房间隔穿刺。 该产品利用射频能量穿透房间隔，穿刺无需较大机械力，提高了操作的安全性。该产品的上市为患者提供了更多的治疗选择。 # 慧扬医疗 | 索引号 | XZXK-2026-10019 | 主题分类 | | --- | --- | --- | | 标题 | 射频穿刺发生器获批上市 | | | 发布日期 | 2026-01-29 | | | 396 | 射频穿刺发生器 | 慧扬医疗科技(苏州) 有限公司 | 2026-1-29 | 江苏 | 国械注准 2026 ...

Group 1 - The State Council issued a work plan to optimize and expand service supply, aiming to enhance service consumption and support high-quality economic development [2] - The work plan focuses on key areas such as transportation services, housekeeping services, and inbound consumption, emphasizing innovation and talent development [2] - The commercial aerospace industry is being prioritized, with plans to develop new fields like space resource development and space tourism during the 14th Five-Year Plan [3] Group 2 - Shanghai aims to become a national hub for the commercial aerospace industry, targeting an industry scale of approximately 100 billion yuan by 2027 [4] - The Beijing humanoid robot innovation center has launched a testing platform, capable of producing 5,000 humanoid robots annually [4] - The Kunshan AI industry fund has been established with a total scale of 5 billion yuan, focusing on AI core hardware and infrastructure [5] Group 3 - The market is experiencing mixed performance, with major U.S. indices showing slight fluctuations [6] - Microsoft shares dropped 10%, marking the largest single-day decline since March 2020, due to concerns over high AI capital expenditures [8] - Gold prices reached a record high of $5,594.82 per ounce before settling at $5,389.19, with a monthly increase of approximately 24% [9]