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維力醫療(603309.SH):完成了一次性使用乳膠導尿管《醫療器械註冊證》變更註冊
格隆匯 02-18 16:49

格隆匯2月18日丨維力醫療(603309.SH)公佈,公司近期收到廣東省藥品監督管理局頒發的《醫療器械註冊變更文件》,公司於2020年2月17日完成了一次性使用乳膠導尿管《醫療器械註冊證》的變更註冊。此次變更主要涉及增加受託生產企業(公司全資子公司海南維力醫療科技開發有限公司,“海南維力”)地址。

註冊證編號:粵械注準20162660874;生產地址:廣州市番禺區化龍鎮金湖工業城C區4號,廣州市番禺區化龍鎮國貿大道南45號、47號,海南省海口國家高新區美安生態科技城美安三街39號(受託生產企業地址);產品名稱:一次性使用乳膠導尿管;型號、規格:單腔導尿管、雙腔導尿管(兒童型、婦女型、標準型)、雙腔彎頭型導尿管、三腔導尿管(兒童型、婦女型、標準型、雙囊型)、四腔導尿管(雙囊A型、雙囊B型),規格:2.0mm(6Fr)~10.0mm(30Fr),帶囊的球囊容積為3~5ml,5ml,5~10ml,10ml,5~15ml,20ml,30ml,50ml,30~50ml,3ml,15ml。結構及組成:一次性使用乳膠導尿管由天然乳膠為主要原材料製成,一次性使用乳膠導尿管由導尿管、助插內芯(有或無)、導尿管塞(有或無)組成。適用範圍:主要用於對患者泌尿系統引流、導尿。批准日期:2016年7月5日;有效期至:2021年7月4日。

此次醫療器械註冊證變更後,公司可以委託全資子公司海南維力生產一次性使用乳膠導尿管,有利於優化公司生產佈局,合理配置產線規劃,更好地滿足市場需求,對公司的未來經營將產生積極影響。

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