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9企业产电子血压计不符合标准规定
2017-09-01 10:05:58 中国经济网
经济日报-中国经济网北京9月1日讯 (记者 吴晓薇)31日,国家食品药品监督管理总局发布了《2017年第19期国家医疗器械质量公告》,公布了无创自动测量血压计(电子血压计)1个品种48台产品的质量监督抽检情况。其中不符合标准规定的医疗器械产品,涉及3家医疗器械生产企业的1个品种3台。标识标签、说明书等项目不符合标准规定的,涉及6家医疗器械生产企业的1个品种8台;全部符合标准规定的医疗器械产品涉及3家医疗器械生产企业的1个品种38台。
其中被抽检项目不符合标准规定的医疗器械产品,涉及3家医疗器械生产企业的1个品种3台,分别为:
无创自动测量血压计(电子血压计)3家企业3台产品。重庆航天火箭电子技术有限公司、深圳市新元素医疗技术开发有限公司生产的各1台电子血压计,可重复性、压力传感器准确性不符合标准规定;东莞市福达康实业有限公司生产的1台臂式全自动电子血压计,指示灯的颜色不符合标准规定。
被抽检项目为标识标签、说明书等项目不符合标准规定的医疗器械产品,涉及6家医疗器械生产企业的1个品种8台,分别为:
无创自动测量血压计(电子血压计)6家企业8台产品。冀州市佳禾医疗器械有限公司、豪展医疗科技(吴江)有限公司生产的各1台、松下电气机器(北京)有限公司生产的2台电子血压计,泰安市迈迪医疗电子有限公司生产的1台电子自动血压计,东莞市福达康实业有限公司生产的1台臂式全自动电子血压计,东莞市好康电子科技有限公司生产的1台臂式全自动电子血压计、1台腕式全自动电子血压计,标识要求不符合标准规定。
对上述抽检中发现的不符合标准规定产品,国家食品药品监督管理总局已要求企业所在地食品药品监督管理部门按照《医疗器械监督管理条例》及《食品药品监管总局办公厅关于进一步加强医疗器械抽验工作的通知》(食药监办械监〔2016〕9号),对相关企业进行调查处理。
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