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新華醫療(600587.SH):醫用空氣壓縮機、X射線血液輻照設備獲得二類和三類醫療器械註冊證
格隆匯 04-07 15:42

格隆匯4月7日丨新華醫療(600587.SH)公佈,公司於近日收到國家藥品監督管理局和山東省藥品監督管理局頒發的《中華人民共和國醫療器械註冊證》。

(一)X射線血液輻照設備(三類醫療器械)

適用範圍:該產品適用於血站或者醫院對袋裝全血類、紅細胞類和血小板類血液製品進行X射線輻照。

雙源X射線血液輻照設備用於輸血前的輻照預處理,具備更安全、輻射均勻性更好、重量輕、易操作的特點。相比現有單源產品,輻照效率更高,在臨牀急救工作中能夠快速高效的提供各類輻照用血,為輸血安全保駕護航。產品可以為多個血液品種提供輻照預處理,為更多種類的疾病患者提供健康安全的血液製品,滿足了特殊病人的輸血需要,對於提升輸血安全具有十分重要的意義。

(二)醫用空氣壓縮機(二類醫療器械)

適用範圍:用於製取醫用壓縮空氣,為呼吸機或類似呼吸通氣系統、醫療機構的集中供氣系統提供壓縮空氣源。

產品採用一用一備的雙路設計理念,採用性能穩定、高能效比的空氣壓縮機作為核心部件,設置多級過濾器及傳感器,同時應用先進的邏輯控制系統,可以實現根據使用流量自動啟停,單機或雙機運行,故障切換運行,空氣質量監測,維護保養提醒,故障報警等功能。相對於行業內很多沒有邏輯控制功能、空氣質量無法保證的拼裝設備,該產品大大提高了產品的穩定性,降低了設備能耗和使用成本,保證了醫用壓縮空氣的質量安全。

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