You are browsing the Hong Kong website, Regulated by Hong Kong SFC (CE number: BJA907). Investment is risky and you must be cautious when entering the market.
魚躍醫療(002223.SZ):子公司浙江凱立特CGM醫療器械註冊證變更
格隆匯 11-09 17:28

格隆匯11月9日丨魚躍醫療(002223.SZ)公佈,公司控股子公司浙江凱立特醫療器械有限公司(簡稱“浙江凱立特”)於近日收到了國家藥監局頒發的關於持續葡萄糖監測系統(簡稱“CGM”)的《醫療器械註冊證變更文件》。該次浙江凱立特CGM醫療器械註冊證變更主要新增了產品型號、規格,對各型產品相應的結構及組成、適用範圍等進行了變更。

變更前,型號、規格:CT2;結構及組成:產品由發射器、接收器、電源適配器(選配)、傳感器(一次性使用無菌產品)組成;適用範圍:本產品適用於糖尿病患者皮下組織液中葡萄糖水平的連續或定期監測。該信息旨在補充而不是替代使用標準葡萄糖監測器械獲得的信息,旨在探測走勢和追蹤圖形,供專業醫生審查,不能作為調整治療的依據。發射器、接收器需與傳感器配合,在醫療機構由經培訓的專業人員操作使用,用於18歲以上成人患者。

變更後,型號、規格:CT2、CT2A、CT2C、CT2D、CT14;結構及組成:產品由發射器、接收器、電源適配器(選配)、一次性葡萄糖傳感器(探頭)、持續葡萄糖數據監測應用程序和醫院血糖管理系統(選配)組成;適用範圍:本產品適用於18歲以上糖尿病成人患者皮下組織液中葡萄糖水平的連續或定期監測。本產品採集信息用於補充而非替代標準葡萄糖監測器械採集信息,可以探測葡萄糖水平走勢和追蹤圖形,供專業醫生審查,不作為調整治療的依據。

公司表示,上述醫療器械註冊證的變更,豐富了公司在CGM領域的產品種類,加強了公司向血糖相關市場提供整體解決方案的能力,推動了CGM產品業務的加速建設。公司將聚焦主要戰略板塊的生產、研發與銷售工作,持續深化糖尿病板塊的市場開發,為公司業績的長期穩定發展創造動力。

Follow us
Find us on Facebook, Twitter , Instagram, and YouTube or frequent updates on all things investing.Have a financial topic you would like to discuss? Head over to the uSMART Community to share your thoughts and insights about the market! Click the picture below to download and explore uSMART app!
Disclaimers
uSmart Securities Limited (“uSmart”) is based on its internal research and public third party information in preparation of this article. Although uSmart uses its best endeavours to ensure the content of this article is accurate, uSmart does not guarantee the accuracy, timeliness or completeness of the information of this article and is not responsible for any views/opinions/comments in this article. Opinions, forecasts and estimations reflect uSmart’s assessment as of the date of this article and are subject to change. uSmart has no obligation to notify you or anyone of any such changes. You must make independent analysis and judgment on any matters involved in this article. uSmart and any directors, officers, employees or agents of uSmart will not be liable for any loss or damage suffered by any person in reliance on any representation or omission in the content of this article. The content of the article is for reference only and does not constitute any offer, solicitation, recommendation, opinion or guarantee of any securities, virtual assets, financial products or instruments. Regulatory authorities may restrict the trading of virtual asset-related ETFs to only investors who meet specified requirements. Any calculations or images in the article are for illustrative purposes only.
Investment involves risks and the value and income from securities may rise or fall. Past performance is not indicative of future performance. Please carefully consider your personal risk tolerance, and consult independent professional advice if necessary.
uSMART
Wealth Growth Made Easy
Open Account