維力醫療(603309.SH):獨家代理百克得的BIP導尿管三類醫療器械註冊證延續獲批
格隆匯3月17日丨維力醫療(603309.SH)公佈,公司獨家代理的瑞典百克得有限公司 Bactiguard AB (“百克得公司”)一次性使用無菌導尿管(“BIP導尿管”)的三類醫療器械註冊證延續於近日獲得國家藥品監督管理局批准,有效期至2027年3月6日。
2018年6月,公司與百克得公司簽署協議,獲得BIP導尿管在中國地區的獨家經銷權以及Bactiguard®塗層技術在中國地區的10年獨家使用權,並於2019年4月在國家藥品監督管理局完成國內代理人備案(註冊證號:國械注進 20153663907),開始BIP導尿管的國內銷售。由於疫情等原因,原註冊證在2020年12月6日到期後的續證工作有所延後。此次BIP導尿管重新獲得國內醫療器械註冊證後,公司作為獨家代理商可以繼續在中國境內銷售BIP導尿管,將進一步提升公司在導尿領域的競爭優勢,促進公司導尿產品升級換代,對公司未來經營業績將會產生積極影響。
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