港股异动 | 时代天使(06699)涨超5% 获TüV南德隐矫产品欧盟MDR-CE证书 推进高标准海外市场准入

智通财经
Jan 08

智通财经APP获悉,时代天使(06699)涨超5%,截至发稿,涨4.57%,报68.7港元,成交额2369.52万港元。

消息面上,据时代天使官网消息,近日,时代天使在上海举办MDR-CE证书授证仪式。TÜV南德意志集团(以下简称"TÜV南德")在授权仪式上为时代天使正式颁发CE实体证书。此次获得国际权威欧盟公告机构(Notified Body)的认可,标志着时代天使隐形矫治相关产品在安全性、有效性及合规性方面全面符合欧盟医疗器械法规要求,也意味着时代天使在高标准海外市场准入上迈出重要一步。

获得MDR-CE证书代表时代天使产品完全满足欧盟对医疗器械安全性、有效性及全生命周期合规性的强制性法律要求,具有极高的国际认可度与市场公信力。时代天使CEO胡杰章在授证仪式上表示,经过两年多的国际化发展,时代天使海外业务增长迅速,今年上半年的国际病例数占总案例数比例已超过50%,业务覆盖60多个国家和地区。此次获得CE认证,是时代天使全球化进程中的重要里程碑,也将进一步夯实公司在国际隐形矫治市场中的竞争基础。

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