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魚躍醫療(002223.SZ):自動體外除顫器產品獲得歐盟MDR認證

格隆匯5月15日丨魚躍醫療(002223.SZ)公佈,公司控股子公司之孫公司MetraxGmbH近日收到了TüVSüDProductServiceGmbH的通知,MetraxGmbH申請的自動體外除顫器(簡稱“AED”)獲得符合歐盟《醫療器械第2017/745號法規》(MedicalDevicesRegulation(EU)2017/745,簡稱“MDR”)要求的III類醫療器械CE認證證書。

本次獲證的AED產品HeartSavemyPAD系列是公司最新一代智能產品,由中德聯合研發製造,融合智能急救技術與工業設計創新,具有顯著的技術優勢與市場競爭力。集成化智能算法與功能,爲急救過程提供更高效的支持與更好的效果;產品重量僅1kg,體積小巧,更加便攜、輕量;可選配可充電電池,確保AED更長時間處於待用狀態,並進一步降低維護成本,同時產品擁有高達1.6米的抗跌落能力,併兼具優異的抗熱、耐凍與防水特性,滿足IP66級防塵防水標準,爲家庭、戶外等複雜急救場景提供了更爲便捷、高效的解決方案。上述產品獲得MDR認證,是公司在急救領域不斷推動產品迭代升級的成果體現,在豐富急救業務產品矩陣的同時,進一步提升了公司急救類產品在相應領域的綜合競爭力。本次獲批將對公司急救業務在全球市場,尤其是歐盟國家及其他認可歐盟MDR認證國家的業務開展有促進作用。公司海內外團隊將持續保持緊密合作,進一步提升產品核心技術競爭力與業務服務能力,助力急救領域相關業務的不斷創新與長期發展。

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