寶萊特(300246.SZ)獲得四項醫療器械註冊證
格隆匯3月3日丨寶萊特(300246.SZ)公佈,公司近日分別獲得國家藥監局、廣東藥監局頒發的4項《醫療器械註冊證》。其中,病人監護儀(P12、P15、P18、P22)註冊分類為Ⅲ類、血液透析器(F12L,F14L,F16L,F18L,F20L)註冊分類為Ⅲ類、監護儀(P1)註冊分類為Ⅲ類、病人監護儀(M850、M860、M880)註冊分類為Ⅱ類。
此次獲批的三類、二類醫療器械註冊證,是公司持續推行研發創新、實施產品高端化、差異化、智能化、物聯化、精品化戰略的結果,豐富了公司產品品類,為公司集團化營銷整合、營銷渠道建設乃至提高公司整體市場拓展能力提供了新的動力和保障,也將為公司抓住國家醫療器械產品“進口替代”、各級醫院升級改造建設的歷史機遇做出更多貢獻做了更多準備。
其中該次獲證的血液透析器的膜材採用了聚醚碸纖維膜,該產品已取得CE認證。此前公司控股子公司蘇州君康已擁有自主研發生產的高通、低通血液透析器醫療器械註冊證。該次獲證,為公司血液淨化產品於多品牌、差異化競爭、全球化銷售中豐富了產品品類,為醫患提供了更多選擇,將增加公司在血液淨化領域的競爭力。未來公司將極大程度發揮蘇州君康的聚醚碸纖維膜生產製造的自主優勢、技術優勢、品質優勢、規模優勢,全力打造為國內血液淨化領域全產業鏈龍頭。
該次獲證的P系列病人監護儀為公司高端智能監護儀產品,是公司潛心“智”造的結合現代人工智能、互聯網、物聯網技術,為醫療機構帶來簡捷、智能、高效、精準體驗的監測產品,可廣泛應用於醫院的ICU、手術室及各種特護病房。
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