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迈瑞公司便携式M5和BS-200获美国FDA许可 - China Medical Device Manufacturer
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Wed, January 17th, 2018

2008年3/4月CMDM电子快讯 » 行业新闻
迈瑞公司便携式M5和BS-200获美国FDA许可

M5是迈瑞公司首台笔记本大小的超声成像设备。

迈瑞医疗设备国际有限公司(中国深圳; www.mindray.com)宣布其生产的便携式M5超声成像系统与BS-200全自动生化分析仪通过美国FDA的510(k)许可。迄今为止,迈瑞已有14种产品获得美国FDA510(k)许可,涵盖病患监视与生命支持产品、体外诊断产品和医疗影像设备3大类别。

迈瑞公司的BS-200全自动生化分析仪旨在替代半自动生化分析仪,
迈瑞公司董事长兼联席首席执行官徐航表示:我们基于中国的独特模式充分利用了世界一流的研发,产品符合全球140多个国家的功能和价格需求。借助最近收购所拓展的美国与欧洲直销与服务网络,我相信我们能进一步提升迈瑞品牌知名度并增加市场份额。(迈瑞日前与Datascope公司签署了收购其生命信息监护业务的最终协议,此举使迈瑞成为全球生命信息监护领域的第三大品牌。)

M5产品仅重6千克,是公司首台笔记本大小的超声成像设备,适宜医生办公场所、诊所与手术室使用,之前,这些地方由于空间与技术限制,无法使用超声成像设备。BS-200全自动生化分析仪旨在替代半自动生化分析仪,面向国际市场上的小型医院和实验室以及中国农村的医院与诊所。还可用作大型医院和实验室的备用仪器。

此外,迈瑞生产的DC-3彩色超声成像系统可广泛应用于腹部、妇产科、内阴、心脏和足疗市场,2008年第一季度通过SFDA许可。此项产品适合寻求替代黑白超声波成像设备的医院和诊所。

2007年第4季度,公司向美国FDA提交了BeneView系列三项产品的许可申请,包括T5、T6 和 T8 多参数病患监视仪器,有望于2008年第2季度获得SFDA对其EX55和EX65紧凑型麻醉机两项产品的批准。


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