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翰宇藥業(300199.SZ):全資子公司完成醫療器械生產許可證變更並取得醫療器械註冊證及醫療器械產品出口銷售證明
格隆匯 04-03 15:57

格隆匯4月3日丨翰宇藥業(300199.SZ)公佈,近日,公司全資子公司甘肅成紀生物藥業有限公司(“成紀藥業”)收到甘肅省藥品監督管理局核准簽發的《醫療器械生產許可證》《中華人民共和國醫療器械註冊證》和《中華人民共和國醫療器械產品出口銷售證明》。

醫療器械生產許可證:生產範圍:舊目錄:Ⅱ類:6815注射穿刺器械;Ⅱ類:6866醫用高分子材料及製品***新目錄:Ⅱ類:14-01注射、穿刺器械;Ⅱ類:14-02血管內輸液器械;Ⅱ類:14-14醫護人員防護用品***;發證日期:2020年4月2日;有效期至:2024年8月1日。

醫療器械註冊證:產品名稱:一次性使用醫用口罩;型號、規格:耳掛式175mm×95mm;耳掛式145mm×95mm;適用範圍:產品用於覆蓋使用者的口、鼻及下頜,在普通醫療環境(非有創醫療操作)中佩戴,阻隔口腔和鼻腔呼出或噴出污染物,一次性使用。批准日期:2020年4月1日;有效期至:2025年3月31日。

醫療器械產品出口銷售證明:產品名稱:一次性使用醫用口罩;規格型號:耳掛式175mm×95mm;耳掛式145mm×95mm;有效期至:2022年4月1號。

成紀藥業已完成醫療器械生產許可證變更並取得一次性使用醫用口罩的醫療器械註冊證和醫療器械產品出口銷售證明,對公司及成紀藥業有積極影響。公司將積極推進相關產品的市場推廣、銷售等工作,繼續切實履行社會責任,竭盡全力保障疫情防控相關物資的供應。

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