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科華生物(002022.SZ):新型冠狀病毒檢測相關產品取得歐盟自由銷售證書
格隆匯 03-17 18:43

格隆匯3月17日丨科華生物(002022.SZ)公佈,公司於2020年3月17日收到關於新型冠狀病毒檢測相關產品的歐盟市場自由銷售證書。獲證產品基本信息如下:

公司上述產品取得歐盟自由銷售證書表明公司上述產品符合歐盟醫療器械相關指令的符合性要求,且已完成歐盟主管當局登記註冊,具備歐盟市場的准入資格。上述產品除了可在歐盟地區銷售外,還可在其他與歐洲經濟區有認可協議的國家銷售,有利於公司拓展國際市場,在全球範圍內助力新型冠狀病毒肺炎疫情的防控工作。公司此次獲得歐盟自由銷售證書的四種新型冠狀病毒檢測試劑,涵蓋了分子診斷與免疫檢測方法學,也包括了適用於有快速診斷需求場合下對全血樣本進行檢測的產品。上述產品的開發和獲證,體現了公司以產品為核心、以市場為導向,聚焦於分子、免疫和生化三大體外診斷檢測領域,快速推出新產品、開拓新市場、迎接新增長的核心戰略。

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