截至目前,与我司合作的诸多企业中,已有15家合作企业成功取得自测CE证书。其中,3家为海外企业、12家为中国企业。IVDEAR可为企业提供国外注册申请的全过程服务,涵盖:法规解读、技术文件咨询服务、技术文件审核协助、发补整改协助、临床实验研究解决方案、非专业人士适用性研究解决方案等等,为企业节省时间,提高效率。
丹大生物研发的新冠病毒抗原自测试剂盒喜获欧盟CE认证,意味着这款产品可以在欧盟成员国及认可欧盟CE证书的国家上市销售,民众可以在超市或者药店购买,自己进行鼻拭子取样、检测,满足了目前各国居家检测防控的需求!
由丹大生物自主研发与生产的新型冠抗原检测试剂盒(胶体金法)(自测版),获得欧盟CE认证!可由个人自行采集前鼻腔拭子样本进行操作,15分钟快速出结果。
IVDEAR还可为企业提供三联检试剂盒(FluA+B+Covid 19)自测CE申请解决方案(临床实验研究解决方案)、Delta、Omicron临床实验研究解决方案、前瞻性临床实验研究解决方案。
IVDEAR(艾维迪亚)是国瑞中安集团旗下重点培育品牌-位于深圳光明新区分支机构。依托国瑞中安集团强有力的资源、渠道和专业背景,IVDEAR专注于为国内外各大企业提供全球各国医疗器械合规化咨询全过程、全方位服务,致力于协助和支持中国本土企业迈向全球化、合规化。
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