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樂心醫療(300562.SZ):獲得醫療器械註冊證 產品名稱為腕式電子血壓計
格隆匯 09-14 21:52

格隆匯9月14日丨樂心醫療(300562.SZ)公佈,公司於近日收南德認證檢測(中國)有限公司(公吿機構號0123TUV SUD)下發基於歐盟醫療器械法規(REGULATION (EU) 2017/745,簡稱MDR)的公吿機構CE符合性證書(證書編號:G10 082800 0048),具體情況如下:

腕式電子血壓計適用於以示波測量成人的收縮壓、舒張壓和脈率,監測血壓變化情況,為用户提供科學的血壓診斷參考。該產品採用 LCD 顯示,測量方式為示波測量法,主要元器件包括氣泵、排氣閥、MCU、傳感器;可測量的手腕周長約13.5cm-21.5cm,能保存99 組測量數據,並能對已存儲的每個記錄進行翻查,也能對用户的測量記錄進行全部刪除,是一款適用於家庭使用的精密血壓測量儀器,該產品小巧、精緻、便攜。

公司致力於成為領先的健康 IoT 及數字健康 SaaS 服務提供商,始終高度重視醫療器械標準符合性,推動全系列產品向醫療級方向發展。歐盟醫療器械法規 REGULATION (EU) 2017/745 頒佈後,公司立即組建專業團隊籌備相關工作,在研發、法規、體系等團隊的共同努力下,公司獲得了TUV SUD 頒發的中國第一張血壓計 CE MDR 證書。上述腕式電子血壓計醫療器械註冊證的取得,將進一夯實醫療級高標準的產品質量優勢,增強公司產品的綜合競爭力和市場拓展能力,有利於公司拓寬海外市場有利於完善公司醫療器械資質體系,對公司未來的經營將產生積極影響。公司未來會積極推動相關產品的銷售,為廣大股東創造更大的價值。上述產品實際銷售情況取決於未來市場推廣效果,公司目前尚無法預測其對公司未來業績的影響。

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