每(mei)經AI快訊，12月(yue)17日(ri)，三鑫醫(yi)(yi)(yi)療公(gong)告，公(gong)司于近(jin)日(ri)收(shou)到歐盟(meng)(meng)醫(yi)(yi)(yi)療器(qi)械(xie)法(fa)(fa)規（MDR）認(ren)證(zheng)證(zheng)書。認(ren)證(zheng)產品包括IIb類(lei)產品：一(yi)次(ci)(ci)性(xing)(xing)(xing)使(shi)(shi)用(yong)空(kong)心纖(xian)維血液(ye)透析器(qi)（低通）、一(yi)次(ci)(ci)性(xing)(xing)(xing)使(shi)(shi)用(yong)空(kong)心纖(xian)維血液(ye)透析器(qi)（高通）；IIa類(lei)產品：一(yi)次(ci)(ci)性(xing)(xing)(xing)使(shi)(shi)用(yong)自(zi)(zi)毀式無菌(jun)注射器(qi)帶針、一(yi)次(ci)(ci)性(xing)(xing)(xing)使(shi)(shi)用(yong)無菌(jun)自(zi)(zi)毀型固定劑(ji)量(liang)疫苗(miao)注射器(qi)帶針、一(yi)次(ci)(ci)性(xing)(xing)(xing)使(shi)(shi)用(yong)無菌(jun)注射器(qi)帶針、一(yi)次(ci)(ci)性(xing)(xing)(xing)使(shi)(shi)用(yong)機用(yong)采血器(qi)、一(yi)次(ci)(ci)性(xing)(xing)(xing)使(shi)(shi)用(yong)血液(ye)透析管(guan)路。MDR作為歐盟(meng)(meng)最(zui)新的醫(yi)(yi)(yi)療器(qi)械(xie)法(fa)(fa)規，對(dui)產品質量(liang)要(yao)求顯著(zhu)提高。公(gong)司取得歐盟(meng)(meng)MDR認(ren)證(zheng)證(zheng)書，表明已建立符合歐盟(meng)(meng)MDR法(fa)(fa)規要(yao)求的質量(liang)管(guan)理體系，產品符合歐盟(meng)(meng)最(zui)新醫(yi)(yi)(yi)療器(qi)械(xie)法(fa)(fa)規要(yao)求，具(ju)備歐盟(meng)(meng)市場最(zui)新準入條件。