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華軟科技(002453.SZ)控股子公司取得醫療器械生產許可證和醫療器械註冊證
格隆匯 03-02 17:12

格隆匯3月2日丨華軟科技(002453.SZ)公佈,2020年2月10日,公司披露了《關於控股子公司開展部分醫療防護物資業務的公告》,為應對醫療防護物資短缺的局面,公司之控股子公司福建省力菲克藥業有限公司(“力菲克藥業”)基於落實當地政府要求,擬開展生產及銷售醫用口罩、醫用防護服、消毒酒精等業務。

2020年3月1日,公司收到力菲克藥業的通知,其已取得福建省藥品監督管理局出具的《醫療器械生產許可證》、《醫療器械註冊證》。

《醫療器械生產許可證》的生產範圍為二類14-14醫護人員防護用品。《醫療器械註冊證》的產品名稱一次性使用醫用口罩、醫用一次性防護服;產品用於應急使用及儲備。註冊證有效期三個月,如疫情結束,自動失效。

此次取得的備案憑證僅在新型冠狀病毒肺炎疫情期間適用,如疫情結束,自動失效。

力菲克藥業將組織各方面力量儘快部署生產安排,積極響應國家應對新型冠狀病毒肺炎疫情防治所需應急物資生產供應和保障的要求。

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