最新应急审评审批产品信息，抗疫物资仍是关键

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                    <section><section data-color="rgb(182, 228, 253)" data-custom="rgb(182, 228, 253)"><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><p><p><img src="image/20201014/86b79d371e9862b01189f0252a03b2cd_1.jpg" /></p></p></section><section><section><span><strong></strong></span></section><p><span>医疗器械媒体报道先锋</span></p><p><span>分享专业医疗器械知识</span></p></section><section><section><section><span>关注</span></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><section><section><section><section><section><section><section><section><section><section><br  /></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section><section><span>2020年1月以来，医疗器械技术审评中心按照“统一指挥、早期介入、随到随审、科学审批”的原则和产品安全、有效、质量可控的要求。</span></section><section><br  /></section><section><span>截至7月16日，已完成44个新型冠状病毒检测试剂盒、13个仪器设备、1个软件、3个敷料产品的应急审评工作，上述61个产品经国家药监局审批获准上市，对比上个月器审中心公布的信息，本月新增应急审评审批产品中新型冠状病毒检测试剂盒2款，新增仪器设备2款，其余产品无变动。</span></section><section><span><br  /></span></section><section><span>可以看出，目前<span>应</span><span>急</span><span>审评审批产品</span>仍然主要集中在抗新冠疫情仪器设备方面，未来一段时间，抗疫物资仍然将是应急审批的重点。</span></section><section><span><br  /></span></section><section><span>汇总如下：</span></section></section></section></section></section><section powered-by="gulangu"><p><br  /></p></section><section powered-by="gulangu"><section><section><br  /></section><section><section opera-tn-ra-cell="_$.pages:0.layers:0.comps:2.col1"><section powered-by="gulangu"><p><strong>检测试剂盒</strong></p></section></section></section><section><br  /></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：新型冠状病毒2019-nCoV核酸检测试剂盒（荧光PCR法）</p><p>注册人名称：上海之江生物科技股份有限公司</p><p>注册证编号：国械注准20203400057</p><p>批准日期：2020-01-26</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：新型冠状病毒2019-nCoV核酸检测试剂盒（荧光PCR法）</p><p>注册人名称：上海捷诺生物科技有限公司</p><p>注册证编号：国械注准20203400058</p><p>批准日期：2020-01-26</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：新型冠状病毒2019-nCoV核酸检测试剂盒（联合探针锚定聚合测序法）</p><p>注册人名称：华大生物科技（武汉）有限公司</p><p>注册证编号：国械注准20203400059</p><p>批准日期：2020-01-26</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：新型冠状病毒2019-nCoV核酸检测试剂盒（荧光PCR法）</p><p>注册人名称：华大生物科技（武汉）有限公司</p><p>注册证编号：国械注准20203400060</p><p>批准日期：2020-01-26</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：新型冠状病毒2019-nCoV核酸检测试剂盒（荧光PCR法）</p><p>注册人名称：中山大学达安基因股份有限公司</p><p>注册证编号：国械注准20203400063</p><p>批准日期：2020-01-28</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：新型冠状病毒2019-nCoV核酸检测试剂盒（荧光PCR法）</p><p>注册人名称：圣湘生物科技股份有限公司</p><p>注册证编号：国械注准20203400064</p><p>批准日期：2020-01-28</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：新型冠状病毒2019-nCoV核酸检测试剂盒（荧光PCR法）</p><p>注册人名称：上海伯杰医疗科技有限公司</p><p>注册证编号：国械注准20203400065</p><p>批准日期：2020-01-31</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：新型冠状病毒（2019-nCoV）抗体检测试剂盒（胶体金法）</p><p>注册人名称：广州万孚生物技术股份有限公司</p><p>注册证编号：国械注准20203400176</p><p>批准日期：2020-02-22</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：新型冠状病毒（2019-nCoV）IgM/IgG抗体检测试剂盒（胶体金法）</p><p>注册人名称：英诺特（唐山）生物技术有限公司</p><p>注册证编号：国械注准20203400177</p><p>批准日期：2020-02-22</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：六项呼吸道病毒核酸检测试剂盒（恒温扩增芯片法）</p><p>注册人名称：成都博奥晶芯生物科技有限公司</p><p>注册证编号：国械注准20203400178</p><p>批准日期：2020-02-22</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：新型冠状病毒2019-nCoV核酸检测试剂盒（荧光PCR法）</p><p>注册人名称：北京卓诚惠生生物科技股份有限公司</p><p>注册证编号：国械注准20203400179</p><p>批准日期：2020-02-27</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：新型冠状病毒（2019-nCoV）IgM抗体检测试剂盒（磁微粒化学发光法）</p><p>注册人名称：博奥赛斯（重庆）生物科技有限公司</p><p>注册证编号：国械注准20203400182</p><p>批准日期：2020-02-29</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：新型冠状病毒（2019-nCoV）IgG抗体检测试剂盒（磁微粒化学发光法）</p><p>注册人名称：博奥赛斯（重庆）生物科技有限公司</p><p>注册证编号：国械注准20203400183</p><p>批准日期：2020-02-29</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：新型冠状病毒2019-nCoV核酸检测试剂盒（荧光PCR法）</p><p>注册人名称：迈克生物股份有限公司</p><p>注册证编号：国械注准20203400184</p><p>批准日期：2020-03-01</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：新型冠状病毒（2019-nCoV）抗体检测试剂盒（磁微粒化学发光法）</p><p>注册人名称：厦门万泰凯瑞生物技术有限公司</p><p>注册证编号：国械注准20203400198</p><p>批准日期：2020-03-06</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：新型冠状病毒（2019-nCoV）IgM抗体检测试剂盒（胶体金法）</p><p>注册人名称：广东和信健康科技有限公司</p><p>注册证编号：国械注准20203400199</p><p>批准日期：2020-03-11</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：新型冠状病毒2019-nCoV核酸检测试剂盒（荧光PCR法）</p><p>注册人名称：武汉明德生物科技股份有限公司</p><p>注册证编号：国械注准20203400212</p><p>批准日期：2020-03-12</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：新型冠状病毒（2019-nCoV）IgM / IgG抗体检测试剂盒（胶体金法）</p><p>注册人名称：南京诺唯赞医疗科技有限公司</p><p>注册证编号：国械注准20203400239</p><p>批准日期：2020-03-13</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：新型冠状病毒（2019-nCoV）IgM/IgG抗体检测试剂盒（胶体金法）</p><p>注册人名称：珠海丽珠试剂股份有限公司</p><p>注册证编号：国械注准20203400240</p><p>批准日期：2020-03-14</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：新型冠状病毒2019-nCoV核酸检测试剂盒（恒温扩增-实时荧光法）</p><p>注册人名称：杭州优思达生物技术有限公司</p><p>注册证编号：国械注准20203400241</p><p>批准日期：2020-03-16</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：新型冠状病毒2019-nCoV核酸检测试剂盒（杂交捕获免疫荧光法）</p><p>注册人名称：安邦（厦门）生物科技股份有限公司</p><p>注册证编号：国械注准20203400298</p><p>批准日期：2020-03-24</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：新型冠状病毒2019-nCoV核酸检测试剂盒（荧光PCR法）</p><p>注册人名称：上海复星长征医学科学有限公司</p><p>注册证编号：国械注准20203400299 &nbsp;</p><p>批准日期：2020-03-24</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：新型冠状病毒2019-nCoV核酸检测试剂盒（RNA捕获探针法）</p><p>注册人名称：上海仁度生物科技有限公司</p><p>注册证编号：国械注准20203400300&nbsp;&nbsp;</p><p>批准日期：2020-03-26</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：新型冠状病毒2019-nCoV核酸检测试剂盒（RNA恒温扩增-金探针层析法）</p><p>注册人名称：武汉中帜生物科技股份有限公司</p><p>注册证编号：国械注准20203400301 &nbsp;</p><p>批准日期：2020-03-31</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：新型冠状病毒2019-nCoV核酸检测试剂盒（双扩增法）</p><p>注册人名称：武汉中帜生物科技股份有限公司</p><p>注册证编号：国械注准20203400302 &nbsp;</p><p>批准日期：2020-03-31</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：新型冠状病毒2019-nCoV核酸检测试剂盒（荧光PCR法）</p><p>注册人名称：北京金豪制药股份有限公司</p><p>注册证编号：国械注准20203400322 &nbsp;</p><p>批准日期：2020-04-03</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：新型冠状病毒（2019-nCoV）IgG抗体检测试剂盒（磁微粒化学发光法）</p><p>注册人名称：丹娜（天津）生物科技有限公司</p><p>注册证编号：国械注准20203400365</p><p>批准日期：2020-04-10</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：新型冠状病毒（2019-nCoV）IgM抗体检测试剂盒（磁微粒化学发光法）</p><p>注册人名称：丹娜（天津）生物科技有限公司</p><p>注册证编号：国械注准20203400366 &nbsp;</p><p>批准日期：2020-04-10</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：新型冠状病毒(2019-nCoV)抗体检测试剂盒（胶体金法）</p><p>注册人名称：上海芯超生物科技有限公司</p><p>注册证编号：国械注准20203400367</p><p>批准日期：2020-04-10</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：新型冠状病毒2019-nCoV核酸检测试剂盒（荧光PCR法）</p><p>注册人名称：江苏硕世生物科技股份有限公司</p><p>注册证编号：国械注准20203400384</p><p>批准日期：2020-04-16</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：新型冠状病毒（2019-nCoV）IgM抗体检测试剂盒（胶体金法）</p><p>注册人名称：北京新兴四寰生物技术有限公司</p><p>注册证编号：国械注准20203400457</p><p>批准日期：2020-05-08</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：新型冠状病毒（2019-nCoV）IgM抗体检测试剂盒（磁微粒化学发光法）</p><p>注册人名称：郑州安图生物工程股份有限公司</p><p>注册证编号：国械注准20203400494 &nbsp;&nbsp;&nbsp;</p><p>批准日期：2020-05-15</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：新型冠状病毒（2019-nCoV）IgG抗体检测试剂盒（磁微粒化学发光法）</p><p>注册人名称：郑州安图生物工程股份有限公司</p><p>注册证编号：国械注准20203400495 &nbsp;&nbsp;&nbsp;</p><p>批准日期：2020-0515</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：新型冠状病毒（2019-nCoV）IgM抗体检测试剂盒（直接化学发光法）&nbsp; &nbsp;&nbsp;</p><p>注册人名称：迈克生物股份有限公司&nbsp; &nbsp;&nbsp;</p><p>注册证编号：国械注准20203400496</p><p>批准日期：2020-05-18</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：新型冠状病毒（2019-nCoV）IgG抗体检测试剂盒（直接化学发光法）&nbsp; &nbsp;&nbsp;</p><p>注册人名称：迈克生物股份有限公司</p><p>注册证编号：国械注准20203400497</p><p>批准日期：2020-05-18</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：新型冠状病毒（2019-nCoV）IgG抗体检测试剂盒（化学发光法）&nbsp; &nbsp;&nbsp;</p><p>注册人名称：博奥赛斯（天津）生物科技有限公司</p><p>注册证编号：国械注准20203400498</p><p>批准日期：2020-05-19</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：新型冠状病毒（2019-nCoV）IgM抗体检测试剂盒（化学发光法）&nbsp; &nbsp;&nbsp;</p><p>注册人名称：博奥赛斯（天津）生物科技有限公司</p><p>注册证编号：国械注准20203400499</p><p>批准日期：2020-05-19</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：新型冠状病毒2019-nCoV核酸检测试剂盒（荧光PCR法）</p><p>注册人名称：浙江东方基因生物制品股份有限公司</p><p>注册证编号：国械注准20203400520</p><p>批准日期：2020-05-21</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：新型冠状病毒（2019-nCoV）抗体检测试剂盒（上转发光免疫层析法）&nbsp; &nbsp;</p><p>注册人名称：北京热景生物技术股份有限公司</p><p>注册证编号：国械注准20203400523</p><p>批准日期：2020-05-25</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：新型冠状病毒2019-nCoV核酸检测试剂盒（荧光PCR法）</p><p>注册人名称：深圳联合医学科技有限公司</p><p>注册证编号：国械注准20203400535</p><p>批准日期：2020-06-05</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：新型冠状病毒（2019-nCoV）IgM/IgG抗体检测试剂盒（量子点荧光免疫法）&nbsp;&nbsp;</p><p>注册人名称：北京金豪制药股份有限公司</p><p>注册证编号：国械注准20203400536</p><p>批准日期：2020-06-09</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：新型冠状病毒2019-nCoV核酸检测试剂盒（荧光PCR法）</p><p>注册人名称：北京纳捷诊断试剂有限公司</p><p>注册证编号：国械注准20203400537</p><p>批准日期：2020-06-09</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：新型冠状病毒（2019-nCoV）IgM/IgG抗体检测试剂盒（酶联免疫法）</p><p>注册人名称：北京华大吉比爱生物技术有限公司</p><p>注册证编号：国械注准20203400567</p><p>批准日期：2020-06-17</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：新型冠状病毒2019-nCoV核酸检测试剂盒（荧光PCR法）</p><p>注册人名称：卡尤迪生物科技宜兴有限公司</p><p>注册证编号：国械注准20203400644</p><p>批准日期：2020-07-13</p></section></section></section></section><section powered-by="gulangu"><p><br  /></p></section><section powered-by="gulangu"><section><section><br  /></section><section><section opera-tn-ra-cell="_$.pages:0.layers:0.comps:48.col1"><section powered-by="gulangu"><p><strong>仪器设备</strong></p></section></section></section><section><br  /></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：基因测序系统</p><p>注册人名称：武汉华大智造科技有限公司</p><p>注册证编号：国械注准20203220061</p><p>批准日期：2020-01-26</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：恒温扩增核酸分析仪</p><p>注册人名称：成都博奥晶芯生物科技有限公司</p><p>注册证编号：国械注准20193220539</p><p>变更日期：2020-02-22</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：恒温扩增微流控芯片核酸分析仪</p><p>注册人名称：成都博奥晶芯生物科技有限公司</p><p>注册证编号：国械注准20173401354</p><p>变更日期：2020-02-22</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：血液净化设备</p><p>注册人名称：威海威高生命科技有限公司</p><p>注册证编号：国械注准20203100180</p><p>批准日期：2020-02-28</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：核酸扩增检测分析仪&nbsp; &nbsp;&nbsp;</p><p>注册人名称：杭州优思达生物技术有限公司</p><p>注册证编号：国械注准20193221026</p><p>变更日期：2020-03-16</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：核酸检测分析仪</p><p>注册人名称：圣湘生物科技股份有限公司</p><p>注册证编号：国械注准20203220419</p><p>批准日期：2020-04-23</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：呼吸机</p><p>注册人名称：北京航天长峰股份有限公司</p><p>注册证编号：国械注准20203080456</p><p>批准日期：2020-04-29</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：呼吸机</p><p>注册人名称：北京谊安医疗系统股份有限公司</p><p>注册证编号：国械注准20163080321</p><p>批准日期：2020-05-12</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：急救呼吸机</p><p>注册人名称：北京谊安医疗系统股份有限公司</p><p>注册证编号：国械注准20153082338</p><p>批准日期：2020-05-12</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：新生儿小儿呼吸机</p><p>注册人名称：深圳迈瑞生物医疗电子股份有限公司</p><p>注册证编号：国械注准20203080493</p><p>批准日期：2020-05-14</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：呼吸机</p><p>注册人名称：北京易世恒电子技术有限责任公司</p><p>注册证编号：国械注准20153082339</p><p>批准日期：2020-05-21</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：同步咳痰机</p><p>注册人名称：濡新（北京）科技发展有限公司</p><p>注册证编号：国械注准20203080594</p><p>批准日期：2020-07-01</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：实时荧光定量PCR仪</p><p>注册人名称：卡尤迪生物科技（北京）有限公司</p><p>注册证编号：国械注准20203220643</p><p>批准日期：2020-07-13</p></section></section></section></section><section powered-by="gulangu"><p><br  /></p></section><section powered-by="gulangu"><section><section><br  /></section><section><section opera-tn-ra-cell="_$.pages:0.layers:0.comps:63.col1"><section powered-by="gulangu"><p><strong>软件产品</strong></p></section></section></section><section><br  /></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：新型冠状病毒2019-nCoV核酸分析软件</p><p>注册人名称：华大生物科技（武汉）有限公司</p><p>注册证编号：国械注准20203210062</p><p>批准日期：2020-01-26</p></section></section></section></section><section powered-by="gulangu"><p><br  /></p></section><section powered-by="gulangu"><section><section><br  /></section><section><section opera-tn-ra-cell="_$.pages:0.layers:0.comps:66.col1"><section powered-by="gulangu"><p><strong>敷料产品</strong></p></section></section></section><section><br  /></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：硅酮粘胶泡沫敷料（有边型）</p><p>注册人名称：施乐辉医用产品（苏州）有限责任公司</p><p>注册证编号：国械注准20173641458</p><p>变更日期：2020-05-26</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：硅酮粘胶复合泡沫敷料</p><p>注册人名称：施乐辉医用产品（苏州）有限责任公司</p><p>注册证编号：国械注准20203140018</p><p>变更日期：2020-05-26</p></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section powered-by="gulangu"><p>产品名称：硅酮粘胶泡沫敷料（有边型）</p><p>注册人名称：Smith &amp; Nephew Medical Ltd.</p><p>注册证编号：国械注进20163644894</p><p>变更日期：2020-05-26</p></section></section></section></section><section powered-by="gulangu"><p><br  /></p><p><span>来源：器审中心</span></p><p><br  /></p></section></section></section></section></section></section></section></section></section></section><section><section data-color="#757576"><section><section><section><section 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