智通财经APP讯,普门科技(688389.SH)公告,公司的26项电化学发光试剂产品以及血红蛋白层析柱获得欧盟公告机构TÜV南德意志集团签发的IVDR CE认证。新的欧盟体外诊断医疗器械法规(IVDR,EU2017/746)替代原欧盟体外诊断医疗器械指令(IVDD,98/79/EC)对欧盟市场的体外诊断医疗器械进行管理。截至目前,公司已有累计53项电化学发光试剂产品获得IVDR CE认证。
智通财经APP讯,普门科技(688389.SH)公告,公司的26项电化学发光试剂产品以及血红蛋白层析柱获得欧盟公告机构TÜV南德意志集团签发的IVDR CE认证。新的欧盟体外诊断医疗器械法规(IVDR,EU2017/746)替代原欧盟体外诊断医疗器械指令(IVDD,98/79/EC)对欧盟市场的体外诊断医疗器械进行管理。截至目前,公司已有累计53项电化学发光试剂产品获得IVDR CE认证。
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