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延安必康(002411.SZ)全資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 04-15 19:00

格隆匯4月15日丨延安必康(002411.SZ)公佈,公司全資孫公司必康製藥新沂集團控股有限公司(“必康新沂”)於2020年4月15日取得了江蘇省藥品監督管理局頒發的醫療器械註冊證及醫療器械生產許可證。

醫療器械註冊證:產品名稱:醫用外科口罩;型號、規格:非滅菌17.5*9.5cm;結構及組成:醫用外科口罩由面罩、定形件、束帶加工而成。產品為一次性使用產品,應非無菌提供。適用範圍:適用於臨牀醫務人員在有創操作等過程中佩戴。有效期至:2021年4月9日。

醫療器械生產許可證:生產範圍:II類:14-14-醫護人員防護用品;有效期至:2021年4月9日。

目前必康新沂已取得醫療器械註冊證以及醫療器械生產許可證,將積極開展醫用外科口罩生產銷售,此次獲取相關資質有利於公司業務發展。

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