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["附件2"]
["国家医疗器械抽验不符合标准规定产品名单"]
["序\n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,"一次性使用无菌注射器-带针","沈阳奉达医疗器械有限公司","沈阳奉达医疗器械有限公司","2ml（针0.5×20）　",20150616,"辽宁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","注射针尺寸"]
[2,"一次性使用无菌注射器-带针","福建省仁德医械制造有限公司","福建省仁德医械制造有限公司","5ml 0.7×28RWLB　",130712,"福建省食品药品监督管理局　","江西省医疗器械检测中心","注射针尺寸"]
[3,"一次性使用无菌注射器-带针","天津市宁河县中医医院","常州市回春医疗器材有限公司","5mL 0.5-21RW·LB　",140626,"天津市市场和质量监督管理委员会　","甘肃省医疗器械检验检测所","注射针尺寸"]
[4,"上肢限制　","泰州市中兴医械科技有限公司","泰州市中兴医械科技有限公司","7孔　",130503118,"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","弯曲强度和等效弯曲刚度"]
[5,"直型接骨板　","北京理贝尔生物工程研究所有限公司","北京理贝尔生物工程研究所有限公司","ZB27-1/3管形 8孔　","生产日期:150128;\n批号:31500001　","北京市食品药品监督管理局　","北京市医疗器械检验所　","弯曲强度和等效弯曲刚度"]
[6,"婴儿培养箱　","上海四菱医用恒温设备有限公司","上海四菱医用恒温设备有限公司","YXK-6G　","生产日期:2015年07月;\n批号:1507120030　","上海市食品药品监督管理局","北京市医疗器械检验所","供电中断报警"]
[7,"调Q Nd:YAG激光治疗机　","重庆京渝激光技术有限公司","重庆京渝激光技术有限公司","MLB-200A　","生产日期:2015年8月;\n出厂编号:MLB-200A-475　","重庆市食品药品监督管理局　","浙江省医疗器械检验院","1.激光输出功率（能量）不稳定度;2. 控制器件和仪表的准确性"]
[8,"HSM-Ⅲ脉冲Nd:YAG激光治疗机　","四川航天世都制导有限公司","四川航天世都制导有限公司","HSM-Ⅲ　","生产日期:2014.10;\n出厂编号:0433　","四川省食品药品监督管理局　","陕西省医疗器械检测中心","激光准备指示器"]
[9,"眼科手术显微镜　","上海轶德医疗设备有限公司","上海轶德医疗设备有限公司","SM-2000L　","生产日期:2015.1;\n出厂编号:B-1407-7　","上海市食品药品监督管理局　","浙江省医疗器械检验院","总放大率误差"]
[10,"NZ20A手术显微镜　","苏州六六视觉科技股份有限公司","苏州六六视觉科技股份有限公司","NZ20A　","出厂日期:2012年04月;\n出厂编号:131000281204　","江苏省食品药品监督管理局　","浙江省医疗器械检验院","总放大率误差"]
[11,"YZ20系列手术显微镜　","苏州六六视觉科技股份有限公司","苏州六六视觉科技股份有限公司","YZ20T4　","出厂日期2015年6月;\n出厂编号:120011661506　","江苏省食品药品监督管理局　","浙江省医疗器械检验院","总放大率误差"]
[12,"手术显微镜　","成都科奥达光电技术有限公司","成都科奥达光电技术有限公司","ASOM-3　","出厂日期:2014.10.16;\n出厂编号: 21001002　","四川省食品药品监督管理局　","浙江省医疗器械检验院","总放大率误差"]
[13,"全数字超声治疗仪　","深圳市威尔德医疗电子有限公司","深圳市威尔德医疗电子有限公司","WED-100　","生产日期:2015-05;\n出厂编号:SI4421057　","广东省食品药品监督管理局　","湖北医疗器械质量监督检验中心","输入功率"]
[14,"超声电导治疗仪　","成都康富科学仪器有限公司","成都康富科学仪器有限公司","ZCD-S1　","生产日期:20150709;\n出厂编号:ZCDS1 20150070　","四川省食品药品监督管理局　","湖北医疗器械质量监督检验中心","额定输出功率准确性"]
[15,"麻醉机　","南京普澳医疗设备有限公司","南京普澳医疗设备有限公司","金陵840型　","产品编号:841501203;\n出厂日期:2015年06月　","江苏省食品药品监督管理局　","上海市医疗器械检测所","1.快速供氧；2.传输气体浓度的准确性"]
[16,"支架铸造合金　","上海璐碧国际贸易有限公司","株式会社RUBY","包装1kg　","TC201418033HK　","上海市食品药品监督管理局　","北京大学口腔医学院口腔医疗器械检验中心","固相线和液相线温度（合金）"]
[17,"牙科用钴铬合金（商品名:JINBEG0-FH）　","南通市今日高科技材料有限公司","南通市今日高科技材料有限公司","支架JR-1-8-16×8×8　",201512,"江苏省食品药品监督管理局　","北京大学口腔医学院口腔医疗器械检验中心","固相线和液相线温度（合金）"]
[18,"牙科用镍铬烤瓷合金（商品名:JINBEG0-N）　","南通市今日高科技材料有限公司","南通市今日高科技材料有限公司","烤瓷JR-3-6.5-10×9×9　",201501,"江苏省食品药品监督管理局　","北京大学口腔医学院口腔医疗器械检验中心","固相线和液相线温度（合金）"]
[19,"牙科用钴铬烤瓷合金（商品名:JINBEG0-C）　","南通市今日高科技材料有限公司","南通市今日高科技材料有限公司","烤瓷JR-4-6.5-16×7×7　",201513,"江苏省食品药品监督管理局　","北京大学口腔医学院口腔医疗器械检验中心","1.固相线和液相线温度（合金）；2.线胀系数"]
[20,"齿科钴铬支架合金　","肯纳司太立金属（上海）有限公司","肯纳司太立金属（上海）有限公司","Stellite C3　",150604,"上海市食品药品监督管理局　","北京大学口腔医学院口腔医疗器械检验中心","0.2%规定非比例延伸强度Rp0.2"]
[21,"呼吸机　","江苏奥凯医疗设备有限公司","江苏奥凯医疗设备有限公司","AV-2000B2","H214091802　","江苏省食品药品监督管理局　","中国食品药品检定研究院","电源软电线"]
[22,"全自动电脑验光仪　","上海雄博精密仪器股份有限公司","上海雄博精密仪器股份有限公司","RM-100",1503101381,"上海市食品药品监督管理局　","解放军总后勤部卫生部药品仪器检验所","清洗、消毒或灭菌措施"]
[23,"丙氨酸氨基转移酶测定试剂盒IFCC法　","安徽信灵检验医学科技有限公司","安徽信灵检验医学科技有限公司","R1:2×60ml R2:1×30ml　",20150219,"安徽省食品药品监督管理局　","北京市医疗器械检验所","线性"]
[24,"风疹病毒IgG抗体检测试剂盒(酶联免疫法)　","珠海经济特区海泰生物制药有限公司","珠海经济特区海泰生物制药有限公司","48人份/盒　",20150504,"广东省食品药品监督管理局　","中国食品药品检定研究院","检出限"]
[25,"风疹病毒IgG抗体检测试剂盒(增强化学发光免疫分析法)　","北京泰格科信生物科技有限公司","北京泰格科信生物科技有限公司","96人份/盒　",20150322,"北京市食品药品监督管理局　","中国食品药品检定研究院","检出限"]
[26,"风疹病毒IgG抗体检测试剂盒（化学发光法）　","北京科卫临床诊断试剂有限公司","北京科卫临床诊断试剂有限公司","96人份/盒　",201506002,"北京市食品药品监督管理局　","中国食品药品检定研究院","阴性符合率"]
[27,"肌酐（CRE）测定试剂盒（肌氨酸氧化酶法）　","北京科美生物技术有限公司","北京科美生物技术有限公司","R1:60ml×5 R2:20ml×5　",150507,"北京市食品药品监督管理局　","北京市医疗器械检验所　","重复性"]
[28,"肌酐测定试剂盒（肌氨酸氧化酶法）","四川新健康成生物股份有限公司","四川新健康成生物股份有限公司","R1 60ml×3;R2 60ml×1　","20150512/0315022　","四川省食品药品监督管理局　","四川省食品药品检验检测院","线性"]
[29,"巨细胞病毒IgG抗体检测试剂盒　","北京现代高达生物技术有限责任公司","北京现代高达生物技术有限责任公司","96人份/盒　",201501001,"北京市食品药品监督管理局　","中国食品药品检定研究院","1.阴性符合率；2.阳性符合率"]
[30,"巨细胞病毒IgG抗体检测试剂盒（酶联免疫法）　","英诺特（唐山）生物技术有限公司","英诺特（唐山）生物技术有限公司","96人份/盒　",20150301,"河北省食品药品监督管理局　","中国食品药品检定研究院","阴性符合率"]
[31,"葡萄糖（Glu）诊断试剂盒（氧化法）　","永和阳光（湖南）生物科技有限公司","永和阳光（湖南）生物科技有限公司","60mL×8　","2015.05.22/GLO 150501　","湖南省食品药品监督管理局","北京市医疗器械检验所","线性"]
[32,"门冬氨酸氨基转移酶测定试剂盒（酶法）　","西门子医学诊断产品（上海）有限公司","Siemens Healthcare Diagnostics Inc.","360测试(4×90测试盒）　","BB6020　","上海市食品药品监督管理局　","北京市医疗器械检验所","线性"]
[33,"天门冬氨酸氨基转移酶测定试剂盒（IFCC推荐法）　","四川新健康成生物股份有限公司","四川新健康成生物股份有限公司","R1:60ml*3;R2:45ml*1　","20150519/0515021　","四川省食品药品监督管理局　","北京市医疗器械检验所","线性"]
[34,"天门冬氨酸氨基转移酶测定试剂盒IFCC法　","安徽信灵检验医学科技有限公司","安徽信灵检验医学科技有限公司","R1:2×60ml R2:1×30ml　",20150219,"安徽省食品药品监督管理局　","北京市医疗器械检验所","线性"]

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