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陽普醫療(300030.SZ):陽普器械取得了國際認證機構TüV SüD新頒發的醫療器械質量體系認證證書等等
格隆匯 06-24 20:58

格隆匯6月24日丨陽普醫療(300030.SZ)公佈,近日,公司全資子公司廣州陽普醫療器械有限公司(“陽普器械”)完成了醫療器械質量體系認證的續期及變更工作,並取得了國際認證機構TüV SüD新頒發的醫療器械質量體系認證證書。

ISO9001體系證書:公司於近期完成了ISO9001體系證書的續期及變更工作,具體變更情況為:認證主體由公司變更為陽普器械,認證範圍新增唾液採集裝置、一次性使用採樣器,刪除POCT系統(包括分析儀和試劑盒)。

MDSAP認證證書:公司於近期完成了MDSAP證書的續期及變更工作,具體變更情況為:認證主體由公司變更為陽普器械,參與並認可MDSAP審核報吿的組織變更為加拿大HC、美國FDA、巴西ANVISA。

此次醫療器械質量體系認證證書的續期及變更實現了母子公司質量體系的順利承接,將有效確保公司生產經營的持續穩定。

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