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正海生物(300653.SZ):醫療器械註冊變更申請獲得受理
格隆匯 09-29 17:08

格隆匯 9 月 29日丨正海生物(300653.SZ)公佈,公司於近日取得國家藥品監督管理局下發的醫療器械註冊許可事項變更的《受理通知書》,受理號為:CQX2000329。產品名稱為生物膜,註冊證編號為國械注準20143132038;註冊證有效期為2019.6.21至2024.6.20;適用範圍為硬腦(脊)膜缺損的修復。

擬變更範圍:將產品名稱“生物膜”變更為“可吸收硬腦(脊)膜補片”。

公司為積極應對高值耗材相關採購政策的實施,開展了必要的市場策略籌劃和部署,此次產品名稱變更系屬於該系列策略中“為保持公司現有產品與國家醫療保障局醫保醫用耗材分類與代碼目錄相一致”而採取的準備工作之一。

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