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愛朋醫療(300753.SZ):“電動注藥泵”獲得醫療器械註冊證
格隆匯 12-14 16:11

格隆匯 12 月 14日丨愛朋醫療(300753.SZ)公佈,公司的全資子公司愛普科學儀器(江蘇)有限公司(“愛普科學”)近日取得國家藥品監督管理局頒發的《中華人民共和國醫療器械註冊證》,產品名稱為電動注藥泵。

愛普科學的“電動注藥泵”是一種微電腦控制下的偏心轉子蠕動泵,由機械組件、電氣組件、軟件組件組成,含微電腦控制、自主參數、精密驅動、全程監控等功能和多重安全保護、中文顯示及低功耗等特點,液晶顯示屏可顯示機器運轉情況和可供醫護人員調節的給藥參數,並且具有電子鎖定功能。該“電動注藥泵”給藥途徑為靜脈給藥、硬膜外給藥兩種,具有持續給藥、自控給藥、持續給藥+自控給藥、首次量(負荷量)+持續給藥+自控給藥四種給藥模式,可滿足不同臨牀應用場景、不同人羣的使用需求。

截至公告披露之日,公司及子公司獲批且在有效期內非一次性的“注藥泵”註冊證共4件,通過國家藥品監督管理局官方網站查詢同類型非一次性注藥泵產品,其他企業獲批且在有效期內的“輸注泵”“注藥泵”註冊證共18件。

上述醫療器械註冊證的取得,豐富了公司疼痛管理領域用第三類醫療器械的產品種類,能夠更好地滿足了市場多樣化的需求,有利於進一步提高公司的市場拓展能力,對公司未來的經營將產生積極影響。

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