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["附件"]
["2021年江苏省医疗器械产品质量监督抽验结果表（不合格） "]
["序号","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","不合格项目"]
[1,"一次性使用医用口罩","扬州华盛医疗科技有限公司","扬州华盛医疗科技有限公司","170×90（±5）（单位：mm）",20210702,"口罩带、通气阻力"]
[2,"医用一次性防护服","江苏天邦医疗科技股份有限公司","江苏天邦医疗科技股份有限公司","连体式 175","2021.01.09/20210109","抗静电性"]
[3,"医用外科口罩","南通泰卫仕医疗科技有限公司","南通泰卫仕医疗科技有限公司","耳挂式 175mm×95mm","20210117/WK20210108","口罩带"]
[4,"一次性使用医用口罩","江苏友奥医疗科技有限公司","江苏友奥医疗科技有限公司","平面耳挂型 17.5cm*9.5cm","2021.01.07/202101002","通气阻力"]
[5,"医用外科口罩","淮阴医疗器械有限公司","淮阴医疗器械有限公司","耳挂式 17.5×9.5cm","2021 01/N210123","压力差△P"]
[6,"医用外科口罩","苏州市晶乐高分子医疗器械有限公司","苏州市晶乐高分子医疗器械有限公司","平面耳挂式175mm*95mm",20210412,"口罩带"]
[7,"医用一次性防护服","宿迁市工人医院","圣光医用制品股份有限公司","连身式 185","批200703","抗静电性"]
[8,"医用一次性防护服","金湖县中医院","河南亚都实业有限公司","连身式175","2020年05月16日/2005CJ5031","抗静电性"]
[9,"医用一次性防护服","徐州仁慈医院","河南省宇安医疗科技开发有限公司","连身式 180","20201209/20120909","断裂强力"]
[10,"医用一次性防护服","徐州市广济连锁药店有限公司福元药店","宇安（河南）控股有限公司","连身式180","2020年11月26日/D20112604","无菌"]
[11,"医用一次性防护服","无锡市第五人民医院","稳健医疗（崇阳）有限公司","连身式 180 604-004246","2020-10-07/20201007-7","抗静电性"]
[12,"医用一次性防护服","盐城市第二人民医院","山东康力医疗器械科技有限公司","连身式 180cm","20201016/20101602","抗静电性"]
[13,"医用一次性防护服","苏北人民医院","安徽天康医疗科技股份有限公司","连身式不含脚套 175","20200730/批200730","断裂强力、抗静电性"]
[14,"降钙素原检测试剂盒（乳胶增强免疫比浊法）","阿里生物技术泰州有限公司","阿里生物技术泰州有限公司","试剂1:36ml×1 试剂2:12ml×1","2021.03.09/2021030901","线性范围"]
[15,"小型医用制氧机","涟水广药医疗器械有限公司","佛山市美客医疗科技有限公司","CP302W","2020.05.03/C03DON200769","辐射发射"]
[16,"一次性医用防护服","无锡华清医院","新乡市金世康医疗器械有限公司","连体式 180","20200810","抗合成血液穿透性"]
[17,"一次性使用直线型吻合器及组件","泰戈斯医疗器械（江苏）有限公司","泰戈斯医疗器械（江苏）有限公司","LTC60G","2019-01-29/CFA011","尺寸"]
[18,"多参数监护仪","徐州市永康电子科技有限公司","徐州市永康电子科技有限公司","YK-8000B","2020-09/机号：0102200800001","心率的测量范围和准确度"]
[19,"医用一次性防护服","泰州妇产医院","山东朱氏药业集团有限公司","185","20201225/批20122503","无菌"]
[20,"一次性使用无菌阴道扩张器","常州市创佳医疗器械有限公司","常州市创佳医疗器械有限公司","M-中号 YKQ-B","20200915","环氧乙烷残留量"]