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啟明醫療(02500.HK)經導管人工肺動脈瓣膜系統獲英國特殊使用許可
阿思達克 03-23 15:11
啟明醫療(02500.HK)公布,核心產品經導管人工肺動脈瓣膜系統VenusP-Valve已獲得英國藥品監管局特殊使用許可,可在指定醫療機構進行使用。

公司表示,特殊使用許可適用於臨床急需且尚未有同類產品上市的醫療產品,VenusP-Valve已於2019年在歐洲申報CE認證,目前處於審評階段,此次特殊使用許可意味著VenusP-Valve在尚未獲得CE認證的情況下,可以提前進入英國市場。

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