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海南海藥(000566.SZ):子公司人工耳蝸產品醫療器械註冊證變更
格隆匯 09-10 22:07

格隆匯9月10日丨海南海藥(000566.SZ)公佈,公司控股子公司上海力聲特醫學科技有限公司(“力聲特”)於近日收到由國家藥品監督管理局頒發的《醫療器械註冊變更文件》註冊證變更內容主要為:力聲特人工耳蝸植入體適用範圍由“適用於年齡在6週歲以上(含6週歲)的雙耳重度或極重度感音神經性聾的語後聾患者”變更為:“適用於年齡在12個月及以上的雙耳重度或極重度感音神經性聾的耳聾患者的聽力重建”。主要信息如下:

次人工耳蝸產品醫療器械註冊證的變更,適用範圍增加覆蓋16歲的兒童,是對公司現有產品的有效補充,增強了公司產品的整體競爭力,將對公司未來的經營發展產生積極影響。

上述產品實際銷售情況取決於未來市場的推廣效果,公司未來將積極推動相關產品的銷售,近期對公司的生產經營和業績不會產生重大影響,敬請投資者注意投資風險。

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