歐普康視(300595.SZ)完成醫療器械註冊證延續註冊
格隆匯3月18日丨歐普康視(300595.SZ)公佈,公司於近日收到國家藥品監督管理局頒發的《中華人民共和國醫療器械註冊證》(註冊證編號:國械注準20163160131),公司原醫療器械註冊證(註冊證編號:國械注準20163220131)現已通過延續註冊審批。
目前所處的註冊審批階段:延續註冊已完成。後續所需的審批流程:無,註冊證有效期至2025年3月1日,有效期到期前需再次申請延續註冊。
公司第三類醫療器械產品“角膜塑形用硬性透氣接觸鏡”的註冊證已完成延續註冊,此次註冊證延續是註冊證有效期的延續,沒有其他實質內容變更。新註冊證(註冊證編號:國械注準20163160131)中載明的材料透氧係數(Dk值)“75×10-11(cm2/s)[mlO2/(ml×hPa)](@35℃)”等同於原註冊證(註冊證編號:國械注準20163220131)中透氧係數“100×10-11(cm2/s)[mlO2/(ml×mmHg)](@35℃)”。新的角膜塑形鏡行業標準YY0477-2016要求使用【(cm2/s)[mlO2/(ml×hPa)](@35℃)】作為透氧係數的單位,因此,將Dk=100×10-11(cm2/s)[mlO2/(ml×mmHg)]@35℃換算到新單位後即為75×10-11(cm2/s)[mlO2/(ml×hPa)](@35℃)。
此次延續註冊的完成,使得公司可以繼續生產和銷售角膜塑形用硬性透氣接觸鏡,對公司未來經營將產生積極影響。上述產品的實際銷售情況取決於未來市場推廣效果,公司目前尚無法預測其對公司未來業績的影響。
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