景峯醫藥(000908.SZ):子公司收到醫療器械生產行政許可
格隆匯 8 月 12日丨景峯醫藥(000908.SZ)公佈,公司全資子公司上海景峯製藥有限公司於近日收到《上海市藥品監督管理局准予行政許可決定書》【受理號:生1395】。
許可證編號:滬食藥監械生產許20201395號;註冊地址:上海市寶山區羅新路50號;生產地址:上海市寶山區羅新路50號;生產範圍(新《分類目錄》):Ⅲ類16-07眼科植入物及輔助器械#;有效期至:2025年08月10日;
審批結論:公司提出的醫療器械生產企業開辦許可申請,經審查,符合法律規定的條件,根據《中華人民共和國行政許可法》第三十八條第一款、《醫療器械監督管理條例》第二十二條第二款和《醫療器械生產監督管理辦法》第十條的規定,上海市藥品監督管理局作出准予行政許可的決定。
2019年9月,國家藥品監督管理局受理公司遞交的“醫用透明質酸鈉凝膠”產品延續註冊申請。延續註冊過程中,公司結合國家標準及產品特性,對標準進行了提高,並於2020年4月獲得批准。
醫用透明質酸鈉凝膠(0.5ml、1.0ml)為第三類醫療器械產品,該品系透明質酸鈉製成的高濃度凝膠,為生物可降解性高分子聚糖類生物材料,無菌、無致畸及致炎性,具有良好的生物相容性及生物學活性。在手術中可作為保護工具和手術工具,廣泛用於各種眼科手術,術中可協助器械將組織輕柔地分離、移動和定位。在眼前節手術中,凝膠注入前房後,使前房加深,便於手術操作,並可保護角膜內皮細胞及眼內組織,減少術後併發症,提高手術成功率,具有較強的市場競爭力。
醫用透明質酸鈉凝膠主要作為手術墊運用於白內障手術,起到臨時支撐手術空間的作用,避免了眼部組織受到手術器械的損傷。
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.