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華懋科技(603306.SH):取得1項《醫療器械生產許可證》、2項《醫療器械註冊證》
格隆匯 06-14 19:24

格隆匯6月14日丨華懋科技(603306.SH)公佈,公司近日取得建省藥品監督管理局頒發的1《醫療器械生產許可證》2《醫療器械註冊證》

醫療器械生產許可證,生產範圍:二類14-14醫護人員防護用品***,發證日期2020611日,有效期限2020910日;

醫療器械註冊證,產品名稱為一次性使用醫用口罩、醫用一次性防護服,註冊證有效期均為2020611-2020910日;

公司此次取得的醫療器械生產許可證、醫療器械註冊證屬疫情應急審批,有效期為三個月如疫情結束,自動失效。臨時證到期自行失效後,企業僅可銷售臨時證有效期內生產的產品,但不得再進行生產。臨時證到期15日前公司申請正式的《醫療器械註冊證》和《醫療器械生產許可證》,如不能獲得新的許可批准,存在不能繼續生產的風險。

公司一次性使用醫用口罩和醫用一次性防護服投產後,產能需要逐步釋放,同時,實際產能還會受到市場訂單、原材料供應、疫情形勢變化及其他多重因素影響。該產品對公司未來業績的影響存在不確定性。

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