聯影醫療(688271.SH):取得醫療器械註冊證
格隆匯6月17日丨聯影醫療(688271.SH)公佈,爲便於投資者瞭解公司近期經營情況,現將上海聯影醫療科技股份有限公司2025年至今取得的境內和主要境外市場醫療器械註冊證情況公告如下:

截至本公告披露日,公司全球註冊覆蓋超80個國家和地區,產品累計獲批上市數量超過140款,其中包括51項產品獲得FDA510(k)認證、52款產品獲得歐盟CE許可,充分體現了公司在全球市場準入方面的綜合實力。在此基礎上,公司在介入影像設備領域取得重大突破:自主研發的數字減影血管造影系統(DSA)uAngioAVIVACX已正式獲得美國FDA510(k)認證,成爲我國首款且目前唯一獲準進入美國市場的國產DSA設備,標誌着公司核心技術產品的國際競爭力達到了新的高度。目前,該產品的歐盟CE認證程序已啓動,公司預計於2025年三季度前完成其在全球主要市場的準入佈局,以期爲全球介入醫學領域提供源於中國的先進解決方案。
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