三鑫醫療(300453.SZ):申報醫用外科口罩、一次性使用醫用口罩醫療器械註冊獲得受理
格隆匯4月22日丨三鑫醫療(300453.SZ)公佈,公司於2020年4月21日收到江西省藥品監督管理局(“江西省藥監局”)下發的“醫用外科口罩”、“一次性使用醫用口罩”兩項產品的《行政許可申請受理通知書》。
公司兩項產品此次獲得江西省第二類醫療器械註冊申請受理,其中:醫用外科口罩以無菌和非無菌兩種形式提供,其產品主要預期用途為“供臨牀醫務人員在有創操作過程中佩戴,覆蓋住使用者的口、鼻及下頜,為防止病原體微生物、顆粒物等的直接透過提供物理屏障”;一次性使用醫用口罩以無菌形式提供,其主要預期用途為“供臨牀各類人員在非有創操作過程中佩戴,覆蓋住使用者的口、鼻及下頜,為防止病原體微生物、顆粒物等的直接透過提供物理屏障”。此前,公司的一次性使用醫用口罩(非無菌)已取得江西省藥監局頒發的醫療器械註冊證,其產品以非無菌形式提供,具體內容詳見公司於2020年3月11日的《關於獲得一次性使用醫用口罩醫療器械註冊證的公告》。
公司此次向江西省藥監局申報“醫用外科口罩”、“一次性使用醫用口罩”第二類醫療器械註冊申請獲得受理,仍需江西省藥監局依法進行一系列評估和審查,公司能否順利取得上述兩項產品的醫療器械註冊證有待於江西省藥監局的最終審評結論。
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