首航高科(002665.SZ)孫公司取得醫療器械註冊證和醫療器械生產許可證
格隆匯3月30日丨首航高科(002665.SZ)公佈,公司於2020年2月24日投資成立全資孫公司天津市首航潔能科技有限公司(“天津首航潔能”),用於生產、銷售醫用口罩,以緩解國內病毒防護所需。公司於2020年3月30日收到天津首航潔能的通知,天津首航潔能已取得由天津市藥品監督管理局核准頒發的《醫療器械註冊證》和《醫療器械生產許可證》。
醫療器械註冊證:產品名稱:一次性使用醫用口罩;型號:平面耳掛式非無菌型;適用範圍:本產品適用於普通醫療環境中,覆蓋住使用者的口、鼻及下頜,阻隔口腔及鼻腔呼出和噴出污染物。
醫療器械生產許可證:生產範圍:Ⅱ類14-14一次性使用醫用口罩。
基於疫情防護的應急需要,公司孫公司天津首航潔能通過綠色審批通道獲得《醫療器械註冊證》和《醫療器械生產許可證》。相關資質獲批後,公司將可以生產醫用防護口罩,滿足國內外疫情防護的需要,產品的銷售將對公司的收入和利潤產生積極影響。
按照相關規定,上述許可到期前,公司可以繼續申請延期或者補充相關資料,申請正式的《醫療器械註冊證》和《醫療器械生產許可證》,屆時若順利獲得將不影響公司後續相關防護正常生產和持續經營。
根據公司佈局生產口罩的計劃安排,在上述口罩生產線投產的同時,公司積極推進海內外營銷渠道的建設。
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