获得国家三类医疗器械注册证及欧盟CEIVDR认证的产品
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圣湘生物:关于自愿披露相关产品取得医疗器械注册证及欧盟CE认证的公告
Zheng Quan Ri Bao· 2025-11-07 13:42
Core Viewpoint - Shengxiang Bio has recently obtained three product certifications and registrations, including two Class III medical device registrations in China and one CE IVDR certification in the European Union [2] Group 1 - Shengxiang Bio announced the acquisition of two Class III medical device registration certificates from the National Medical Products Administration [2] - The company also received a CE IVDR certification, which is essential for marketing medical devices in the European market [2]