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["附件1"]
["国家医疗器械抽验不符合标准规定的产品名单"]
["序号","标示产品名称","被抽查单位","标示生产企业","规格型号","生产日期/批号        /出厂编号","抽样单位","检验单位","不符合标准规定项"]
[1,"HA系列表式半导体激光治疗仪　","泰州市华安科技有限公司","泰州市华安科技有限公司","HA-04型　",2114070298,"江苏省食品药品监督管理局　","吉林省医疗器械检验所","1.标记-一般要求"]
[2,"HA系列表式半导体激光治疗仪　","泰州市华安科技有限公司","泰州市华安科技有限公司","HA-03型　",2114070148,"江苏省食品药品监督管理局　","吉林省医疗器械检验所","1.标记-一般要求"]
[3,"半导体激光治疗仪　","南京亿高微波系统工程有限公司","南京亿高微波系统工程有限公司","ECO-600B　",6041403,"江苏省食品药品监督管理局　","吉林省医疗器械检验所","1.外壳和防护罩；2.遥控联锁连接器；3.标记-窗口标记；4.脉冲持续时间（脉冲宽度）"]
[4,"便携式吸痰器　","江苏登冠医疗器械有限公司","江苏登冠医疗器械有限公司","7E-A　","生产日期：2014.07；出厂编号/批号：0049　","江苏省食品药品监督管理局　","上海市医疗器械检测所","1.设备或设备部件的外部标记-外部可触及的熔断器的型号和额定值"]
[5,"便携式吸痰器　","江苏江航医疗设备有限公司","江苏江航医疗设备有限公司","ZH-H11","生产日期：2014.04.08；出厂编号/批号：1404010304　","江苏省食品药品监督管理局　","上海市医疗器械检测所","1.设备或设备部件的外部标记-输入功率；2.设备或设备部件的外部标记-分类；3.设备或设备部件的外部标记-防电击程度；4.设备或设备部件的外部标记-运行模式；5.设备或设备部件的外部标记-外部可触及的熔断器的型号和额定值；6.指示灯的颜色；7.收集容器的入口孔"]
[6,"便携式吸痰器　","江苏康尚医疗器械有限公司","江苏康尚医疗器械有限公司","9E-A　","生产日期：2014年05月18日；出厂编号/批号：14051201177","江苏省食品药品监督管理局　","上海市医疗器械检测所","1.收集容器的入口孔"]
[7,"低负压吸引器　","江苏科凌医疗器械有限公司","江苏科凌医疗器械有限公司","DFX-Ⅲ","生产日期：2014.6；出厂编号/批号：270606145160　","江苏省食品药品监督管理局　","上海市医疗器械检测所","1.设备或设备部件的外部标记-型式标记；2.设备或设备部件的外部标记-输入功率；3.设备或设备部件的外部标记-标记的耐久性；4.外壳的封闭性"]
[8,"电动吸引器　","江苏科凌医疗器械有限公司","江苏科凌医疗器械有限公司","DFX-23C·I　","生产日期：2014.8；出厂编号/批号：160806146079","江苏省食品药品监督管理局　","上海市医疗器械检测所","1.设备或设备部件的外部标记-标记的耐久性；2.外壳的封闭性"]
[9,"电动人工流产吸引器　","江苏科凌医疗器械有限公司","江苏科凌医疗器械有限公司","DFX-IV·C　","生产日期：2014.8；出厂编号/批号：220806146222　","江苏省食品药品监督管理局　","上海市医疗器械检测所","1.外壳的封闭性"]
[10,"电动吸引器　","江苏富林医疗设备有限公司","江苏富林医疗设备有限公司","H002　","生产日期：2014.04.28；产品编号：000101","江苏省食品药品监督管理局　","上海市医疗器械检测所","1.输入功率"]
[11,"臂式电子血压计　","杭州世佳电子有限公司","杭州世佳电子有限公司","BP-1319　",140417,"浙江省食品药品监督管理局　","湖南省医疗器械与药用包装材料检测所","1.设备或设备部件的外部标记-输入功率2.标识要求-电源系统标识"]
[12,"臂式电子血压计　","江苏江航医疗设备有限公司","江苏江航医疗设备有限公司","ZH-B14　","生产日期：20140405；批号：1404010716　","江苏省食品药品监督管理局　","山东省医疗器械产品质量检验中心","1.标识要求"]
[13,"腕式电子血压计　","江苏江航医疗设备有限公司","江苏江航医疗设备有限公司","ZH-C13　","生产日期：20140703；批号：1407010369　","江苏省食品药品监督管理局　","山东省医疗器械产品质量检验中心","1.标识要求"]
[14,"全自动手臂式电子数显血压计　","杭州华安医疗保健用品有限公司","杭州华安医疗保健用品有限公司","MB-300C　",20130406,"浙江省食品药品监督管理局　","湖南省医疗器械与药用包装材料检测所","1.标识要求"]
[15,"全自动腕式血压计　","信利仪器（汕尾）有限公司","信利仪器（汕尾）有限公司","DW702　","出厂编号：NX071324　","广东省食品药品监督管理局　","湖南省医疗器械与药用包装材料检测所","1.标识要求"]
[16,"腕式全自动电子血压计　","深圳市合发医疗器械有限公司","深圳市合发医疗器械有限公司","HF-A11　","批号：201406　","广东省食品药品监督管理局　","湖南省医疗器械与药用包装材料检测所","1.标识要求"]
[17,"KRL-HY100P型多参数监护仪　","重庆康如来科技有限公司","重庆康如来科技有限公司","KRL-HY100P型　","出厂日期：2012年1月；出厂编号/批号：F0012010003","重庆市食品药品监督管理局　","上海市医疗器械检测所","1.指示灯的颜色；2.外壳的封闭性；3.不用工具就可打开的罩和门的安全性；4.外壳及零部件强度；5.心电监护设备的非正常工作指示"]
[18,"多参数监护仪　","深圳市乐夫科技有限公司","深圳市乐夫科技有限公司","LF-6000B　","生产日期：2014年7月；出厂编号/批号：C200014T0153　","广东省食品药品监督管理局　","上海市医疗器械检测所","1.指示器；2.心电监护设备的非正常工作指示"]
[19,"高压电位治疗仪","天津市唐邦科技有限公司","天津市唐邦科技有限公司","TB-6800C型　","出厂日期：2014年07月10日；编号：1407039　","天津市食品药品监督管理局","天津市医疗器械质量监督检验中心","1.安全要求-外部标记"]
[20,"中频干扰电治疗仪　","南京鼎世医疗器械有限公司","南京鼎世医疗器械有限公司","DS-MF1A　","P001-140601/002　","江苏省食品药品监督管理局　","河北省医疗器械与药品包装材料检验研究院","1.设备或设备部件的外部标记-可拆卸的保护装置"]
[21,"RAY系列牙科X射线机　","宁波蓝野医疗器械有限公司","宁波蓝野医疗器械有限公司","RAY68（M）　","生产日期：2014年08月；出厂编号：M1408056　","浙江省食品药品监督管理局　","辽宁省医疗器械检验检测院","1.正常使用时的稳定性；2.网电源熔断器和过电流释放器"]
[22,"单牙X射线机　","天津市三美齿科医疗器械制造有限公司","天津市三美齿科医疗器械制造有限公司","SMX-I型　","生产日期：20140725；出厂编号：14046037　","天津市食品药品监督管理局　","辽宁省医疗器械检验检测院","1.输入功率-其他设备"]
[23,"LED医用内窥镜冷光源　","桐庐精锐医疗器械有限公司","桐庐精锐医疗器械有限公司","JRL-II　","产品编号：JRL-II20140151　","浙江省食品药品监督管理局　","浙江省医疗器械检验院","1.显色指数；2.相关色温；3.红绿蓝光的辐通量比；4.光照均匀性；5.输出总光通量"]
[24,"微波治疗仪　","南京福中医疗高科有限公司","南京福中医疗高科有限公司","METI-IVC　","C140723031　","江苏省食品药品监督管理局　","天津市医疗器械质量监督检验中心","样机开机后不能正常工作"]
[25,"婴儿培养箱　","南京金陵自动调温床有限公司","南京金陵自动调温床有限公司","NC-Y4C　","2014-408　","江苏省食品药品监督管理局　","内蒙古自治区医疗器械检测中心","1.设备或设备部件的外部标记-网电源功率输出"]
[26,"一次性使用气管切开插管　","南京宏安医疗科技有限公司","南京宏安医疗科技有限公司","FR26 6.5mm 带囊　","生产日期:20140801;批号:20140801　","江苏省食品药品监督管理局　","广东省医疗器械质量监督检验所","1.长度"]
[27,"一次性使用气管切开插管　","浙江海圣医疗器械有限公司","浙江海圣医疗器械有限公司","QKCG-7.5A　","批号:14070519　","浙江省食品药品监督管理局　","广东省医疗器械质量监督检验所","1.长度"]
[28,"定制式固定义齿　","岑溪市家乐义齿加工厂","岑溪市家乐义齿加工厂","非贵金属为主体材料金属铸造烤瓷桥　","出厂日期:2014.8.1；\n批号:JL147270　","广西壮族自治区食品药品监督管理局　","广东省医疗器械质量监督检验所","1.孔隙度"]
[29,"定制式固定义齿　","遂宁市佳鸿义齿制作有限公司","遂宁市佳鸿义齿制作有限公司","金属合金铸造烤瓷冠桥　","生产日期:2014年8月3日；编号:521431300085-0086　","四川省食品药品监督管理局　","广东省医疗器械质量监督检验所","1.孔隙度"]
[30,"定制式固定义齿　","天津市天天义齿制作中心","天津市天天义齿制作中心","镍铬合金烤瓷冠（桥）　","编号：30117663；制作日期：2014-7-21　","天津市食品药品监督管理局　","广东省医疗器械质量监督检验所","1.孔隙度"]
[31,"定制式固定义齿　","天津市西青区优然美义齿制作中心","天津市西青区优然美义齿制作中心","钴铬合金烤瓷桥　","编号：072159　","天津市食品药品监督管理局　","广东省医疗器械质量监督检验所","1.孔隙度"]
[32,"金属烤瓷固定修复体　","东莞市乐天义齿制造有限公司","东莞市乐天义齿制造有限公司","定制式　","生产日期:2014.07.10；编号:E3774　","广东省食品药品监督管理局　","广东省医疗器械质量监督检验所","1.孔隙度"]
[33,"金属烤瓷固定修复体　","东莞市石碣美粤陶瓷加工厂","东莞市石碣美粤陶瓷加工厂","规格:冠、桥　","生产日期:2014-09-06；牙模编号:201409104；订单编号:0007536　","广东省食品药品监督管理局　","广东省医疗器械质量监督检验所","1.孔隙度"]
[34,"金属烤瓷固定修复体　","广东粤诚牙科技术开发中心","广东粤诚牙科技术开发中心","无","编号:140915046　","广东省食品药品监督管理局　","广东省医疗器械质量监督检验所","1.孔隙度"]
[35,"金属烤瓷固定修复体　","珠海市三通陶齿有限公司","珠海市三通陶齿有限公司","无","订单编号:0017504 ；批号:140817167　","广东省食品药品监督管理局　","广东省医疗器械质量监督检验所","1.孔隙度"]
[36,"金属烤瓷固定修复体(钴铬合金烤瓷)　","佛山市南海区里水爵冠义齿有限公司","佛山市南海区里水爵冠义齿有限公司","定制式　","出厂日期:2014年9月3日；产品编号:R97059　","广东省食品药品监督管理局　","广东省医疗器械质量监督检验所","1.孔隙度"]
[37,"定制式固定义齿　","吉林市吉美义齿加工所","吉林市吉美义齿加工所","无","编号：14070401 出货日期：14年7月7日　","吉林省食品药品监督管理局　","广东省医疗器械质量监督检验所","1.耐急冷急热性能"]
[38,"定制式固定义齿　","陕西前进齿科新技术开发有限公司","陕西前进齿科新技术开发有限公司","定制式固定义齿　","模型编号:1470733　","陕西省食品药品监督管理局　","广东省医疗器械质量监督检验所","1.耐急冷急热性能"]
[39,"定制式固定义齿　","通辽市名洋义齿有限责任公司","通辽市名洋义齿有限责任公司","无","无","内蒙古自治区食品药品监督管理局　","广东省医疗器械质量监督检验所","1.耐急冷急热性能"]
[40,"金属烤瓷固定修复体　","珠海思诚义齿有限公司","珠海思诚义齿有限公司","无","订单编号:B1409030009　","广东省食品药品监督管理局　","广东省医疗器械质量监督检验所","1.耐急冷急热性能"]
[41,"定制式固定义齿　","东莞定远陶齿制品有限公司","东莞定远陶齿制品有限公司","钴铬合金烤瓷钢牙复合桥型　","收件日期:2014.9.5；牙模编号:P4905HSR96AA　","广东省食品药品监督管理局　","广东省医疗器械质量监督检验所","1.设计单；2.耐急冷急热性能"]
[42,"定制式义齿　","重庆登峰义齿制作有限责任公司","重庆登峰义齿制作有限责任公司","DF-GA　","出厂日期:2014-7-23；产品编号：29407351　","重庆市食品药品监督管理局　","广东省医疗器械质量监督检验所","1.制作设计单 2.修复体设计"]
[43,"定制式活动义齿　","广西南宁澳特医疗设备有限责任公司","广西南宁澳特医疗设备有限责任公司","无","工厂出件日期:2014年7月23日　","广西壮族自治区食品药品监督管理局　","广东省医疗器械质量监督检验所","1.铸造连接体和卡环的厚度"]
[44,"定制式活动义齿　","南宁瓷都忠诚义齿制造有限公司","南宁瓷都忠诚义齿制造有限公司","无","设计单号:0039438　","广西壮族自治区食品药品监督管理局　","广东省医疗器械质量监督检验所","1.铸造连接体和卡环的厚度"]
[45,"定制式活动义齿　","遂宁市佳鸿义齿制作有限公司","遂宁市佳鸿义齿制作有限公司","金属支架可摘局部义齿　","生产日期:2014年8月3日；编号:521431400087-0088　","四川省食品药品监督管理局　","广东省医疗器械质量监督检验所","1.铸造连接体和卡环的厚度"]
[46,"定制式活动义齿　","天津好美利义齿技术开发合伙企业（普通合伙）","天津好美利义齿技术开发合伙企业（普通合伙）","钴铬合金支架局部义齿　","ZW177　","天津市食品药品监督管理局　","广东省医疗器械质量监督检验所","1.设计单"]
[47,"金属骨针-圆型骨针4×300　","常州市康辉医疗器械有限公司","常州市康辉医疗器械有限公司","Φ4×300　","批号：414004140","江苏省食品药品监督管理局　","天津市医疗器械质量监督检验中心","1.表面粗糙度"]
[48,"鼻氧管　","宁波蓝柏医疗器械有限公司","宁波蓝柏医疗器械有限公司","型号：LB-BYG-I，规格：成人L直头　","生产日期：20140516；批号：140516　","浙江省食品药品监督管理局　","福建省药品检验所","1.密封性"]
[49,"一次性使用鼻氧管　","常州市环康医疗器械有限公司","常州市环康医疗器械有限公司","双鼻式　",20140616,"江苏省食品药品监督管理局　","山东省医疗器械产品质量检验中心","1.密封性"]
[50,"一次性使用鼻氧管　","江苏耀华医疗器械科技有限公司","江苏耀华医疗器械科技有限公司","大号/双鼻型　","生产日期：20140804；批号：1408P001　","江苏省食品药品监督管理局　","山东省医疗器械产品质量检验中心","1.密封性"]
[51,"一次性使用惰气保护真空采血管　","汕头市金丰医疗器械科技有限公司","汕头市金丰医疗器械科技有限公司","12×75mm　",140703,"广东省食品药品监督管理局　","山东省医疗器械产品质量检验中心","1.容量"]
[52,"医用防护口罩　","绍兴振德医用敷料有限公司","绍兴振德医用敷料有限公司","11×13cm-3P（N95）　",140821,"浙江省食品药品监督管理局　","河南省医疗器械检验所","1.密合性"]
[53,"医用防护口罩　","绍兴振德医用敷料有限公司","绍兴振德医用敷料有限公司","11×13cm-3P（N95）　",140822,"浙江省食品药品监督管理局　","河南省医疗器械检验所","1.密合性"]
[54,"尿素氮检测试剂盒（速率法）　","威特曼生物科技（南京）有限公司","威特曼生物科技（南京）有限公司","100mL(R1：2×40mL；R2：1×20mL)　","批号：FBU14198　","江苏省食品药品监督管理局　","北京市医疗器械检验所","1.线性范围"]
[55,"乳酸脱氢酶检测试剂盒（速率法）　","威特曼生物科技（南京）有限公司","威特曼生物科技（南京）有限公司","100mL(R1：2×40mL；R2：1×20mL)　","批号：XRT14155　","江苏省食品药品监督管理局　","北京市医疗器械检验所","1.线性范围"]
[56,"总蛋白检测试剂（双缩脲法）　","希森美康生物科技（无锡）有限公司","希森美康生物科技（无锡）有限公司","60mL×2瓶/盒　","批号：R4005　","江苏省食品药品监督管理局　","北京市医疗器械检验所","1.线性"]

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