三鑫醫療(300453.SZ):獲得醫療器械註冊證
格隆匯7月16日丨三鑫醫療(300453.SZ)公佈,公司於近日取得國家藥品監督管理局頒發的《醫療器械註冊證》,現將主要情況公吿如下:

公司此前已經註冊的低通量血液透析器外殼採用聚碳酸酯材料,此次新獲得注冊證的一次性使用血液透析器為血蓋及外殼採用聚丙烯材料的低通量透析器。此次獲證後,將進一步補充公司血液透析器的規格種類,公司將有分別採用聚碳酸酯材料和聚丙烯材料的低通、高通透析器同時在市場銷售,能夠更好地滿足臨牀不同的使用需求。
此次獲證的血液透析濃縮液是含鈣濃度為1.25mmol/L的低鈣透析濃縮液,近年來高鈣、高磷及鈣磷乘積升高使透析患者高鈣負荷和重要臟器轉移性鈣化明顯加速,心血管疾病危險性顯著上升,新獲證的血液透析濃縮液可以減輕高鈣負荷和轉移性鈣化的發生,能夠滿足不同患者的個性化需求。
此次新獲證的產品有利於豐富公司產品結構,提升公司的核心競爭力與市場拓展能力,對公司未來發展將產生積極影響。但該產品的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具體影響。
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