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["附件3"]
["医疗器械注册审查指导原则公开征求意见的通知征求意见稿联系方式"]
["序号","指导原则名称","牵头单位","联系人","联系电话","电子邮箱","通信地址","邮编"]
[1,"电动摄影平床注册审查指导原则（征求意见稿）","北京市医疗器械审评检查中心","张谦",18010283730,"13862188@qq.com","北京市西城区水车胡同13号",100035]
[2,"医用气体报警系统注册审查指导原则（征求意见稿）","浙江省医疗器械审评中心","夏建松","0571-89779830","158542134@qq.com","浙江省杭州市上城区环城东路23号407室（浙江省医疗器械审评中心）",310000]
[3,"空氧混合器产品注册审查指导原则（征求意见稿）","广东药品监督管理局审评认证中心","陈虹蓁","020-37886797","2102858721@qq.com","广东省广州市越秀区东风东路753号之二1408室",510000]
[4,"激光定位系统产品注册审查指导原则（征求意见稿）","四川省食品药品审查评价及安全监测中心","孙健","028-61321559","344943669@qq.com","四川省成都市高新区科园南路69号金蓉大厦6楼618",610093]
[5,"神经和肌肉刺激器用体内电极注册审查指导原则（征求意见稿）","江苏省药品监督管理局审评中心","王文娟",15850590190,"267355323@qq.com","江苏省南京市中山东路448号普华大厦",210002]
[6,"中医脉诊设备产品注册审查指导原则（征求意见稿）","天津市医疗器械审评查验中心","崔涛",13820164518,"52278313@qq.com","天津市南开区红旗南路237号",300000]
[7,"康复训练床注册审查指导原则（征求意见稿）","江苏省药品监督管理局审评中心","吴佳妮",13951002143,"15165016100@163.com","江苏省南京市中山东路448号普华大厦",210002]
[8,"医用妇科凝胶注册审查指导原则 （征求意见稿）","山东省食品药品审评查验中心","王晓晨","0531-51795653","shenpingsanbu2023@163.com","山东省济南市历下区经十路16122号",250014]
[9,"一次性使用输氧面罩产品注册审查指导原则（征求意见稿）","陕西省药品技术审评中心","于聪颖",19991857753,"SP617128@163.com","陕西省西安市雁塔区高新六路56号",710065]
[10,"雾化面罩产品注册审查指导原则（征求意见稿）","河南省药品审评查验中心","姜珊",15694142586,"1075807496@qq.com","河南省郑州市金水区花园路127号 河南省药品监督管理局 "]
[11,"支气管堵塞器注册审查指导原则（征求意见稿）","江西省药品认证审评中心","姜常胜","0791-86239556","3430834531@qq.com","南昌市八一大道415号",330006]
[12,"医用导管固定装置产品注册审查指导原则（征求意见稿）","湖北省药品监督管理局审评中心","王婷",18571579279,"339447382@qq.com","湖北省武汉市武昌区公正路19号",430071]
[13,"呼吸面罩注册审查指导原则","山东省食品药品审评查验中心","王晓晨","0531-51795653","shenpingsanbu2023@163.com","山东省济南市历下区经十路16122号",250014]
[14,"辅助生殖用显微操作管注册审查指导原则(征求意见稿)","上海市医疗器械化妆品审评核查中心","余小燕",13764157365,"56159822@qq.com","上海市黄浦区南昌路210号",200020]
[15,"医用透明质酸钠创面敷料注册审查指导原则（征求意见稿）","天津市医疗器械审评查验中心","陈永霞",15692299267,"543317847@qq.com","天津市南开区红旗南路238号",300000]
[16,"电解质分析仪注册审查指导原则（征求意见稿）","福建省药品审评与监测评价中心","马仁俊",15859097178,"574860172@qq.com","福建省福州市鼓楼区东浦路156号展企大厦601室",350003]
[17,"葡萄糖检测试剂注册审查指导原则（征求意见稿）","四川省食品药品审查评价及安全监测中心","王海舟",17360013538,"276071866@qq.com","四川省成都市高新区科园南路69号金蓉大厦",610000]
[18,"革兰阴性杆菌鉴定试剂注册审查指导原则（征求意见稿）","河南省药品审评查验中心","栗梦婷",15093310959,"877068322@qq.com","河南省郑州市金水区花园路127号河南省药品审评查验中心",450003]
[19,"丙酮酸检测试剂注册审查指导原则（征求意见稿）","江苏省药品监督管理局审评中心","蔡瑶","025-84535281","caiy@jspcc.org.cn","江苏省南京市中山东路448号普华大厦",210002]
[20,"α-淀粉酶检测试剂注册审查指导原文（征求意见稿）","河北省医疗器械技术审评中心","谢颖","0311-67305173","hbqsivd@163.com","河北省石家庄市桥西区新石中路375号","050000"]
[21,"α-羟丁酸脱氢酶检测试剂注册审查指导原则（征求意见稿）","重庆市药品技术审评查验中心","方陈城",15111980068,"839625938@qq.com","重庆市渝北区食品城大道27号",4011120]
[22,"镁检测试剂注册审查指导原则（征求意见稿）","上海市医疗器械化妆品审评核查中心","周游",18917603712,"zhouyou@smda.sh.cn","上海市黄浦区南昌路210号",200020]
[23,"半自动化学发光免疫分析仪注册审查指导原则（2023年修订版）（征求意见稿）","广东省药品监督管理局审评认证中心","吴林蔚","020-37886310","635759702@qq.com","广东省广州市东风东路753号之二1403",510080]
[24,"牙科综合治疗机注册审查指导原则（2023年修订版）（征求意见稿)","广东省药品监督管理局审评认证中心","王康","020-37886521","2885403635@qq.com","广东省广州市越秀区东风东路753号之二1506室",510000]
[25,"助听器注册审查指导原则（2023年修订版）（征求意见稿)","广东省药品监督管理局审评认证中心","赖锦坝","020-37886051","2885403634@qq.com","广东省广州市越秀区东风东路753号之二1506室",510000]
[26,"X射线诊断设备（第二类）注册审查指导原则（2023年修订版）（征求意见稿）","广东省药品监督管理局审评认证中心","陈卓","020-37886030","2885407538@qq.com","广东省广州市越秀区东风东路753号之二1506室",510000]
[27,"医用雾化器注册审查指导原则（2023年修订版）（征求意见稿)","广东省药品监督管理局审评认证中心","魏增江","020-37885036","2885411696@qq.com","广东省广州市越秀区东风东路753号之二1506室",510000]
[28,"肌酸激酶检测试剂注册审查指导原则（2023年修订版）（征求意见稿）","北京市医疗器械审评检查中心","郭丽丽",18010281630,"guolili@yjj.beijing.gov.cn","北京市西城区水车胡同13号",100035]
[29,"正压通气治疗机注册审查指导原则（2023年修订版）（征求意见稿）","北京市医疗器械审评检查中心","张高亮",18010285076,"gaoliang1212@163.com","北京市西城区水车胡同13号",100035]
[30,"磁疗产品注册技术审查指导原则（2023年修订版）(征求意见稿)","北京市医疗器械审评检查中心","曹昱",13381288729,"1570289671@qq.com","北京市西城区水车胡同13号",100035]
[31,"凝血分析仪注册审查指导原则（2023年修订版）（征求意见稿)","北京市医疗器械审评检查中心","赵强",18010208064,"zhaoqiang@yjj.beijing.gov.cn","北京市西城区水车胡同13号",100035]
[32,"医用内窥镜冷光源注册审查指导原则（2023年修订版）（征求意见稿）","北京市医疗器械审评检查中心","巩玉香",18010281616,"ylqx321@126.com","北京市西城区水车胡同13号",100035]
[33,"唾液酸检测试剂盒（酶法）注册审查指导原则（2023年修订版）（征求意见稿）","重庆市药品技术审评查验中心","文李铃",13368121265,"276101426@qq.com","重庆市渝北区食品城大道27号",4011120]
[34,"β2-微球蛋白检测试剂注册审查指导原则（2023年修订版）（征求意见稿）","重庆市药品技术审评查验中心","党英萍",15902358683,"50872579@qq.com","重庆市渝北区食品城大道27号",4011120]
[35,"乳酸脱氢酶测定试剂盒注册审查指导原则（2023年修订版）（征求意见稿）","重庆市药品技术审评查验中心","方陈城",15111980068,"839625938@qq.com","重庆市渝北区食品城大道27号",4011120]
[36,"促甲状腺素检测试剂注册审查指导原则（2023修订版）（征求意见稿）","重庆市药品技术审评查验中心","高丽丽",18580552936,"602335506@qq.com","重庆市渝北区食品城大道27号",4011120]
[37,"缺血修饰白蛋白测定试剂盒注册审查指导原则（2023年修订版）（征求意见稿）","重庆市药品技术审评查验中心","谭嘉熙",15823525378,"121375024@qq.com","重庆市渝北区食品城大道27号",4011120]
[38,"糖化血红蛋白测定试剂盒（酶法）注册审查指导原则（2023年修订版）（征求意见稿）","重庆市药品技术审评查验中心","刘芮均",15680683780,"274791561@qq.com","重庆市渝北区食品城大道27号",4011120]
[39,"振动叩击排痰机注册审查指导原则（2023年修订版）（征求意见稿）","吉林省药品审评中心","于阳",18210038096,"Yu_Y_55@163.com","吉林省长春市南关区幸福街1888号",130000]
[40,"尿液分析仪注册审查指导原则（2023年修订版）（征求意见稿)","吉林省药品审评中心","吴宪",18643031928,"598902326@qq.com","吉林省长春市南关区幸福街1888号",130000]
[41,"腹膜透析设备注册审查指导原则（2023年修订版）（征求意见稿)","吉林省药品审评中心","李娟",18686434383,"406134995@qq.com","吉林省长春市南关区幸福街1888号",130000]
[42,"c反应蛋白测定试剂盒注册审查指导原则（2023年修订版）（征求意见稿)","吉林省药品审评中心","潘晓恒",13944098186,"63559460@qq.com","吉林省长春市南关区幸福街1888号",130000]
[43,"医学影像存储与传输系统软件（PACS）注册审查指导原则（2023年修订版）（征求意见稿)","吉林省药品审评中心","白一然",13134308389,"2575241997@qq.com","吉林省长春市南关区幸福街1888号",130000]
[44,"尿液有形成分分析仪注册审查指导原则（2023年修订版）（征求意见稿）","山东省食品药品审评查验中心","任希力","（0531）51795626","shenpingsibu@shandong.cn","济南市历下区经十路16122号",250014]
[45,"大型蒸汽灭菌器注册审查指导原则（2023年修订版）（征求意见稿）","山东省食品药品审评查验中心","赵立国","（0531）51795627","shenpingsibu@shandong.cn","济南市历下区经十路16122号",250014]
[46,"碱性磷酸酶检测试剂注册审查指导原则（2023年修订版）（征求意见稿）","山东省食品药品审评查验中心","崔涛","（0531）51795660","shenpingsibu@shandong.cn","济南市历下区经十路16122号",250014]
[47,"血液透析制水设备注册审查指导原则（2023年修订版）（征求意见稿）","山东省食品药品审评查验中心","徐琨","（0531）51795626","shenpingsibu@shandong.cn","济南市历下区经十路16122号",250014]
[48,"甘油三酯检测试剂注册审查指导原则（2023年修订版）（征求意见稿）","山东省食品药品审评查验中心","崔涛","（0531）51795660","shenpingsibu@shandong.cn","济南市历下区经十路16122号",250014]
[49,"血糖仪注册审查指导原则（2023年修订版）（征求意见稿）","天津市医疗器械审评查验中心","于庆洁",15122638022,"2392829455@qq.com","天津市南开区红旗南路239号",300000]
[50,"人绒毛膜促性腺激素检测试剂（胶体金免疫层析法）注册审查指导原则（2023年修订版）（征求意见稿）","天津市医疗器械审评查验中心","杜瑶",16602657601,"1141576797@qq.com","天津市南开区红旗南路240号",300000]
[51,"白蛋白测定试剂（盒）注册审查指导原则（2023年修订版）（征求意见稿）","天津市医疗器械审评查验中心","陈雨萱",17320099013,"chenyyyxxx@163.com","天津市南开区红旗南路241号",300000]
[52,"大便隐血（FOB）检测试剂盒（胶体金免疫层析法）注册审查指导原则（2023年修订版）（征求意见稿）","天津市医疗器械审评查验中心","张瑜",18822029533,"1172456309@qq.com","天津市南开区红旗南路242号",300000]
[53,"电子血压计（示波法）注册审查指导原则（2023年修订版）（征求意见稿）","天津市医疗器械审评查验中心","孙恩惠",18322741800,"641398993@qq.com","天津市南开区红旗南路243号",300000]
[54,"生化分析仪注册审查指导原则（2023年修订版）（征求意见稿）","天津市医疗器械审评查验中心","王朝壹",18402273516,"wangzhaoyi_work@qq.com","天津市南开区红旗南路244号",300000]

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