2017年4月CFDA共批准90个注册医疗器械产品

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                    <section data-role="outer" label="owered by gulangu"><section><p><p><img src="image/20200927/4410641dc33cc803c94b828eb633ac94_1.png" /></p></p><p><p><img src="image/20200927/7f9ec093343ce7785dd7d980397fcaaa_2.png" /></p></p><p><span>2</span><span>017年4月，国家食品药品监督管理总局共批准注册医疗器械产品90个。其中，境内第三类医疗器械产品43个，进口第三类医疗器械产品14个，进口第二类医疗器械产品33个。（具体产品见附件）。</span></p><p><span>&nbsp;</span></p><p><span>特此公告。</span></p><p><span>&nbsp;</span></p><p><span><strong>附件：2017</strong><strong>年4</strong><strong>月批准注册医疗器械产品目录</strong></span></p><p><br  /></p></section><section data-role="outer" label="owered by gulangu"><table height="4640"><tbody><tr height="34" data-bgless="lighten" data-bglessp="30%"><th width="18">序号</th><th width="90">产品名称</th><th width="212">注册人名称</th><th width="127">注册证编号</th></tr><tr height="20"><td colspan="4" x:str="" height="15" width="58">境内第三类医疗器械</td></tr><tr height="47" data-bgless="lighten" data-bglessp="30%"><td x:num="1" height="35">1</td><td x:str="" height="35">一次性高频切开刀</td><td x:str="" height="35">上海英诺伟医疗器械有限公司</td><td x:str="" height="35" width="58">国械注准20173220558</td></tr><tr height="47"><td x:num="2" height="35">2</td><td x:str="" height="35">高压电位治疗仪</td><td x:str="" height="35">苏州久久寿医疗器械有限公司</td><td x:str="" height="35" width="58">国械注准20173260559</td></tr><tr height="60" data-bgless="lighten" data-bglessp="30%"><td x:num="3" height="45">3</td><td x:str="" height="45">等离子射频手术系统</td><td x:str="" height="45">方润医疗器械科技（上海）有限公司</td><td x:str="" height="45" width="58">国械注准20173250560</td></tr><tr height="60"><td x:num="4" height="45">4</td><td x:str="" height="45">麻醉机</td><td x:str="" height="45">通用电气医疗系统（中国）有限公司</td><td x:str="" height="45" width="58">国械注准20173540561</td></tr><tr height="60" data-bgless="lighten" data-bglessp="30%"><td x:num="5" height="45">5</td><td x:str="" height="45">病人监护仪</td><td x:str="" height="45">飞利浦金科威（深圳）实业有限公司</td><td x:str="" height="45" width="58">国械注准20173210562</td></tr><tr height="60"><td x:num="6" height="45">6</td><td x:str="" height="45">可变角双探头单光子发射计算机断层成像设备</td><td x:str="" height="45">北京永新医疗设备有限公司</td><td x:str="" height="45" width="58">国械注准20173330681</td></tr><tr height="47" data-bgless="lighten" data-bglessp="30%"><td x:num="7" height="35">7</td><td x:str="" height="35">磁定位型射频消融导管</td><td x:str="" height="35">上海微创电生理医疗科技有限公司</td><td x:str="" height="35" width="58">国械注准20173770682</td></tr><tr height="47"><td x:num="8" height="35">8</td><td x:str="" height="35">高频内窥镜手术电极</td><td x:str="" height="35">凯卓科技（北京）有限公司</td><td x:str="" height="35" width="58">国械注准20173220683</td></tr><tr height="47" data-bgless="lighten" data-bglessp="30%"><td x:num="9" height="35">9</td><td x:str="" height="35">一次性腹腔穿刺器</td><td x:str="" height="35">东莞麦可龙医疗科技有限公司</td><td x:str="" height="35" width="58">国械注准20173150684</td></tr><tr height="47"><td x:num="10" height="35">10</td><td x:str="" height="35">X射线计算机体层摄影系统</td><td x:str="" height="35">深圳安科高技术股份有限公司</td><td x:str="" height="35" width="58">国械注准20173300685</td></tr><tr height="47" data-bgless="lighten" data-bglessp="30%"><td x:num="11" height="35">11</td><td x:str="" height="35">一次性使用电圈套器</td><td x:str="" height="35">常州乐奥医疗科技股份有限公司</td><td x:str="" height="35" width="58">国械注准20173220686</td></tr><tr height="47"><td x:num="12" height="35">12</td><td x:str="" height="35">全自动化学发光免疫分析仪</td><td x:str="" height="35">北京热景生物技术有限公司</td><td x:str="" height="35" width="58">国械注准20173403157</td></tr><tr height="47" data-bgless="lighten" data-bglessp="30%"><td x:num="13" height="35">13</td><td x:str="" height="35">呼吸机</td><td x:str="" height="35">北京思瑞德医疗器械有限公司</td><td x:str="" height="35" width="58">国械注准20173543158</td></tr><tr height="47"><td x:num="14" height="35">14</td><td x:str="" height="35">高频手术系统</td><td x:str="" height="35">杭州得道医疗设备科技有限公司</td><td x:str="" height="35" width="58">国械注准20173253159</td></tr><tr height="47" data-bgless="lighten" data-bglessp="30%"><td x:num="15" height="35">15</td><td x:str="" height="35">一次性使用血压传感器</td><td x:str="" height="35">浙江苏嘉医疗器械股份有限公司</td><td x:str="" height="35" width="58">国械注准20173213171</td></tr><tr height="47"><td x:num="16" height="35">16</td><td x:str="" height="35">电子上消化道内窥镜</td><td x:str="" height="35">上海嘉望内窥镜技术有限公司</td><td x:str="" height="35" width="58">国械注准20173223172</td></tr><tr height="60" data-bgless="lighten" data-bglessp="30%"><td x:num="17" height="45">17</td><td x:str="" height="45">麻醉系统</td><td x:str="" height="45">通用电气医疗系统（中国）有限公司</td><td x:str="" height="45" width="58">国械注准20173543173</td></tr><tr height="60"><td x:num="18" height="45">18</td><td x:str="" height="45">麻醉机</td><td x:str="" height="45">通用电气医疗系统（中国）有限公司</td><td x:str="" height="45" width="58">国械注准20173543174</td></tr><tr height="47" data-bgless="lighten" data-bglessp="30%"><td x:num="19" height="35">19</td><td x:str="" height="35">电子膀胱肾盂内窥镜</td><td x:str="" height="35">杭州好克光电仪器有限公司</td><td x:str="" height="35" width="58">国械注准20173223175</td></tr><tr height="61"><td x:num="20" height="45">20</td><td x:str="" height="45">6-单乙酰吗啡检测试剂盒（胶体金法）</td><td x:str="" height="45">艾博生物医药（杭州）有限公司</td><td x:str="" height="45" width="58">国械注准20173400590</td></tr><tr height="60" data-bgless="lighten" data-bglessp="30%"><td x:num="21" height="45">21</td><td x:str="" height="45">总前列腺特异性抗原校准品（化学发光法）</td><td x:str="" height="45">四川迈克生物科技股份有限公司</td><td x:str="" height="45" width="58">国械注准20173400601</td></tr><tr height="61"><td x:num="22" height="45">22</td><td x:str="" height="45">糖类抗原125校准品（化学发光法）</td><td x:str="" height="45">四川迈克生物科技股份有限公司</td><td x:str="" height="45" width="58">国械注准20173400602</td></tr><tr height="47" data-bgless="lighten" data-bglessp="30%"><td x:num="23" height="35">23</td><td x:str="" height="35">肿瘤标志物质控品</td><td x:str="" height="35">四川迈克生物科技股份有限公司</td><td x:str="" height="35" width="58">国械注准20173400603</td></tr><tr height="47"><td x:num="24" height="35">24</td><td x:str="" height="35">糖类抗原19-9校准品（化学发光法）</td><td x:str="" height="35">四川迈克生物科技股份有限公司</td><td x:str="" height="35" width="58">国械注准20173400604</td></tr><tr height="47" data-bgless="lighten" data-bglessp="30%"><td x:num="25" height="35">25</td><td x:str="" height="35">柔性金属丝</td><td x:str="" height="35">北京中安泰华科技有限公司</td><td x:str="" height="35" width="58">国械注准20173460591</td></tr><tr height="47"><td x:num="26" height="35">26</td><td x:str="" height="35">胶原蛋白海绵</td><td x:str="" height="35">重庆可劳德生物技术有限公司</td><td x:str="" height="35" width="58">国械注准20173640592</td></tr><tr height="47" data-bgless="lighten" data-bglessp="30%"><td x:num="27" height="35">27</td><td x:str="" height="35">全降解鼻窦药物支架系统</td><td x:str="" height="35">浦易（上海）生物技术有限公司</td><td x:str="" height="35" width="58">国械注准20173460679</td></tr><tr height="47"><td x:num="28" height="35">28</td><td x:str="" height="35">经皮介入人工心脏瓣膜系统</td><td x:str="" height="35">杭州启明医疗器械有限公司</td><td x:str="" height="35" width="58">国械注准20173460680</td></tr><tr height="47" data-bgless="lighten" data-bglessp="30%"><td x:num="29" height="35">29</td><td x:str="" height="35">介入人工生物心脏瓣膜</td><td x:str="" height="35">苏州杰成医疗科技有限公司</td><td x:str="" height="35" width="58">国械注准20173460698</td></tr><tr height="60"><td x:num="30" height="45">30</td><td x:str="" height="45">一次性使用正压静脉留置针</td><td x:str="" height="45">河南曙光健士医疗器械集团股份有限公司</td><td x:str="" height="45" width="58">国械注准20173150720</td></tr><tr height="47" data-bgless="lighten" data-bglessp="30%"><td x:num="31" height="35">31</td><td x:str="" height="35">金属直型接骨板</td><td x:str="" height="35">大博医疗科技股份有限公司</td><td x:str="" height="35" width="58">国械注准20173460721</td></tr><tr height="47"><td x:num="32" height="35">32</td><td x:str="" height="35">金属髓内针</td><td x:str="" height="35">苏州欣荣博尔特医疗器械有限公司</td><td x:str="" height="35" width="58">国械注准20173460722</td></tr><tr height="47" data-bgless="lighten" data-bglessp="30%"><td x:num="33" height="35">33</td><td x:str="" height="35">造影导管</td><td x:str="" height="35">辽宁垠艺生物科技股份有限公司</td><td x:str="" height="35" width="58">国械注准20173770723</td></tr><tr height="47"><td x:num="34" height="35">34</td><td x:str="" height="35">金属骨针</td><td x:str="" height="35">苏州欣荣博尔特医疗器械有限公司</td><td x:str="" height="35" width="58">国械注准20173460724</td></tr><tr height="47" data-bgless="lighten" data-bglessp="30%"><td x:num="35" height="35">35</td><td x:str="" height="35">一次性使用造影用高压连接管</td><td x:str="" height="35">深圳市益心达医学新技术有限公司</td><td x:str="" height="35" width="58">国械注准20173663162</td></tr><tr height="47"><td x:num="36" height="35">36</td><td x:str="" height="35">空心螺钉系统</td><td x:str="" height="35">江苏博朗森思医疗器械有限公司</td><td x:str="" height="35" width="58">国械注准20173463163</td></tr><tr height="47" data-bgless="lighten" data-bglessp="30%"><td x:num="37" height="35">37</td><td x:str="" height="35">解剖型金属接骨板</td><td x:str="" height="35">江苏艾为康医疗器械科技有限公司</td><td x:str="" height="35" width="58">国械注准20173463164</td></tr><tr height="47"><td x:num="38" height="35">38</td><td x:str="" height="35">一次性使用静脉输液针</td><td x:str="" height="35">江苏康华医疗器材有限公司</td><td x:str="" height="35" width="58">国械注准20173153165</td></tr><tr height="47" data-bgless="lighten" data-bglessp="30%"><td x:num="39" height="35">39</td><td x:str="" height="35">金属锁定接骨板钉系统</td><td x:str="" height="35">厦门中科兴医疗器械有限公司</td><td x:str="" height="35" width="58">国械注准20173463166</td></tr><tr height="47"><td x:num="40" height="35">40</td><td x:str="" height="35">一次性使用静脉留置针</td><td x:str="" height="35">上海宝舜医疗器械有限公司</td><td x:str="" height="35" width="58">国械注准20173153167</td></tr><tr height="47" data-bgless="lighten" data-bglessp="30%"><td x:num="41" height="35">41</td><td x:str="" height="35">一次性使用输液器带针</td><td x:str="" height="35">浙江欧健保灵医疗设备有限公司</td><td x:str="" height="35" width="58">国械注准20173663168</td></tr><tr height="47"><td x:num="42" height="35">42</td><td x:str="" height="35">空心接骨螺钉</td><td x:str="" height="35">北京德益达美医疗科技有限公司</td><td x:str="" height="35" width="58">国械注准20173463169</td></tr><tr height="47" data-bgless="lighten" data-bglessp="30%"><td x:num="43" height="35">43</td><td x:str="" height="35">隐形眼镜润滑液</td><td x:str="" height="35">雅培眼力健（杭州）制药有限公司</td><td x:str="" height="35" width="58">国械注准20173223170</td></tr><tr height="20"><td colspan="4" x:str="" height="15" width="58">进口第三类医疗器械</td></tr><tr height="64" data-bgless="lighten" data-bglessp="30%"><td x:num="44" height="48">44</td><td x:str="" height="48">超声诊断系统</td><td x:str="" height="48">Siemens&nbsp;Medical&nbsp;Solutions&nbsp;USA,&nbsp;Inc.</td><td x:str="" height="48" width="58">国械注进20173231079</td></tr><tr height="64"><td x:num="45" height="48">45</td><td x:str="" height="48">超声诊断系统</td><td x:str="" height="48">Siemens&nbsp;Medical&nbsp;Solutions&nbsp;USA,&nbsp;Inc.</td><td x:str="" height="48" width="58">国械注进20173231080</td></tr><tr height="64" data-bgless="lighten" data-bglessp="30%"><td x:num="46" height="48">46</td><td x:str="" height="48">超声诊断系统</td><td x:str="" height="48">Siemens&nbsp;Medical&nbsp;Solutions&nbsp;USA,&nbsp;Inc.</td><td x:str="" height="48" width="58">国械注进20173231081</td></tr><tr height="47"><td x:num="47" height="35">47</td><td x:str="" height="35">移动式C形臂X射线机</td><td x:str="" height="35">Siemens&nbsp;AG</td><td x:str="" height="35" width="58">国械注进20173301082</td></tr><tr height="47" data-bgless="lighten" data-bglessp="30%"><td x:num="48" height="35">48</td><td x:str="" height="35">移动式C形臂X射线机</td><td x:str="" height="35">Siemens&nbsp;AG</td><td x:str="" height="35" width="58">国械注进20173301083</td></tr><tr height="48"><td x:num="49" height="36">49</td><td x:str="" height="36">X射线立体定向放射治疗系统</td><td x:str="" height="36">Accuray&nbsp;Incorporated</td><td x:str="" height="36" width="58">国械注进20173321084</td></tr><tr height="47" data-bgless="lighten" data-bglessp="30%"><td x:num="50" height="35">50</td><td x:str="" height="35">射频治疗仪</td><td x:str="" height="35">Alma&nbsp;Lasers&nbsp;Ltd</td><td x:str="" height="35" width="58">国械注进20173255133</td></tr><tr height="48"><td x:num="51" height="36">51</td><td x:str="" height="36">心血管造影图像分析软件</td><td x:str="" height="36">ie&nbsp;Medical&nbsp;Imaging&nbsp;B.V.</td><td x:str="" height="36" width="58">国械注进20173705134</td></tr><tr height="47" data-bgless="lighten" data-bglessp="30%"><td x:num="52" height="35">52</td><td x:str="" height="35">支气管导航系统</td><td x:str="" height="35">Covidienllc</td><td x:str="" height="35" width="58">国械注进20173225135</td></tr><tr height="48"><td x:num="53" height="36">53</td><td x:str="" height="36">透明带红外激光光学系统</td><td x:str="" height="36">Research&nbsp;Instruments&nbsp;Ltd</td><td x:str="" height="36" width="58">国械注进20173245136</td></tr><tr height="48" data-bgless="lighten" data-bglessp="30%"><td x:num="54" height="36">54</td><td x:str="" height="36">全自动化学发光免疫分析仪</td><td x:str="" height="36">Abbott&nbsp;Laboratories</td><td x:str="" height="36" width="58">国械注进20173405137</td></tr><tr height="47"><td x:num="55" height="35">55</td><td x:str="" height="35">血糖仪</td><td x:str="" height="35">CNOGA&nbsp;Medical&nbsp;Ltd.</td><td x:str="" height="35" width="58">国械注进20173405138</td></tr><tr height="64" data-bgless="lighten" data-bglessp="30%"><td x:num="56" height="48">56</td><td x:str="" height="48">一次性使用活检针</td><td x:str="" height="48">AJUNK&nbsp;GmbH&nbsp;Medizintechnologie</td><td x:str="" height="48" width="58">国械注进20173151134</td></tr><tr height="47"><td x:num="57" height="35">57</td><td x:str="" height="35">膝关节假体</td><td x:str="" height="35">ERMEDICA&nbsp;S.P.A.</td><td x:str="" height="35" width="58">国械注进20173465139</td></tr><tr height="20" data-bgless="lighten" data-bglessp="30%"><td colspan="4" x:str="" height="15" width="58">进口第二类医疗器械</td></tr><tr height="47"><td x:num="58" height="35">58</td><td x:str="" height="35">移动式C形臂X射线机</td><td x:str="" height="35">株式会社島津製作所</td><td x:str="" height="35" width="58">国械注进20172301076</td></tr><tr height="48" data-bgless="lighten" data-bglessp="30%"><td x:num="59" height="36">59</td><td x:str="" height="36">一次性同芯圆针电极</td><td x:str="" height="36">Natus&nbsp;Manufacturing&nbsp;Limited</td><td x:str="" height="36" width="58">国械注进20172211077</td></tr><tr height="80"><td x:num="60" height="60">60</td><td x:str="" height="60">电动手术台</td><td x:str="" height="60">TRUMPF&nbsp;MedizinSysteme&nbsp;GmbH+Co.KG</td><td x:str="" height="60" width="58">国械注进20172541078</td></tr><tr height="48" data-bgless="lighten" data-bglessp="30%"><td x:num="61" height="36">61</td><td x:str="" height="36">脉搏血氧饱和度和血压测量仪</td><td x:str="" height="36">LD&nbsp;TECHNOLOGY&nbsp;LLC</td><td x:str="" height="36" width="58">国械注进20172211217</td></tr><tr height="47"><td x:num="62" height="35">62</td><td x:str="" height="35">动力系统</td><td x:str="" height="35">Bien-Air&nbsp;Surgery&nbsp;SA</td><td x:str="" height="35" width="58">国械注进20172541218</td></tr><tr height="47" data-bgless="lighten" data-bglessp="30%"><td x:num="63" height="35">63</td><td x:str="" height="35">移动式摄影X射线机</td><td x:str="" 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