普门科技(688389.SH)获多项产品获IVDR CE认证

智通财经2025-11-20

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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