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戴维医疗:公司申报医疗器械电动手术台注册获得受理
Xin Lang Cai Jing· 2025-09-02 08:33
戴维医疗公告称,公司于近日取得1项由浙江省药品监督管理局颁发的《受理通知书》,受理号为:械 受20254028265。本次申报产品为电动手术台,采用电动液压控制方式,通过微型按键开关控制器灵活 控制台面的各种运动,以满足手术所需的各种体位要求。上述医疗器械产品目前所处的审批阶段为注册 申请受理,后续所需的审批流程为技术审评、行政审批、制证。上述品种注册申请受理对公司近期业绩 不会产生影响,后续各阶段所需的时间和结果均具有一定的不确定性。 ...
国家药监局新批295个医疗器械,哪些地区相关企业最多?
Sou Hu Cai Jing· 2025-08-22 07:57
广东省、山东省、江苏省医疗器械相关企业数量位居前列,三个省市数量总和超过161.1万余家,占企业总数的26.9% 从区域分布来看,广东省、山东省、江苏省医疗器械相关企业数量位居前列,三个省市数量总和超过161.1万余家,占企业总数的26.9%。排在其后的是河 南省和北京市,分别拥有相关企业超37.1万余家和35.8万余家。 据国家药监局消息显示,2025年7月,国家药监局在医疗器械注册审批方面有新进展,发布了批准注册相关产品的公告。 此外,通过天眼查天眼风险和深度风险来看,涉及司法案件的医疗器械相关企业约占总数的2.4%。 此次批准注册的医疗器械产品数量颇为可观,总数达到295个。从产品来源和类别看,境内第三类医疗器械产品占据多数,有240个;进口第三类医疗器械 产品为21个;进口第二类医疗器械产品有29个;港澳台医疗器械产品有5个。 医疗器械的注册审批关乎医疗行业的健康发展与民众的医疗安全。国家药监局严格把关,批准众多医疗器械产品注册,既为医疗市场注入新活力,丰富产 品种类,满足多样医疗需求,也体现了监管部门保障医疗器械质量、推动行业规范发展的决心。 投资时间网、标点财经快讯 天眼查专业版数据显示,截至目前 ...
透景生命:申报医疗器械注册获受理
news flash· 2025-06-16 07:58
Core Viewpoint - The company and its wholly-owned subsidiary, Shanghai Toukang Diagnostic Technology Co., Ltd., have recently received acceptance for their medical device registration applications from the Shanghai Municipal Drug Administration, which includes seven products across various diagnostic fields [1] Group 1: Product Registration - The accepted products include carcinoembryonic antigen, cytokeratin 19 fragment, neuron-specific enolase, squamous cell carcinoma antigen, gastrin-releasing peptide precursor assay kit (flow fluorescence method), 25-hydroxyvitamin D assay kit (chemiluminescent immunoassay), anti-double-stranded DNA antibody, anti-C1q antibody, anti-M2-3E antibody, anti-nucleosome antibody, and anti-phospholipid syndrome IgA antibody assay kit (flow fluorescence method) [1] - These products cover tumor detection, metabolic detection, and autoimmune detection, which will help enrich the company's product line, meet market demand, and enhance market competitiveness [1] Group 2: Approval Process - The current stage of the approval process is the acceptance of the registration application, with subsequent steps including technical review, administrative approval, and issuance of the license [1] - The acceptance of these product registration applications will not have an impact on the company's or Toukang Diagnostic's recent performance [1]