成立于1997年,國內較具規模的一次性醫療器械產品研發生產基地,自毀型一次性使用注射器行業佼佼者
無錫市宇壽醫(yi)療(liao)器械有(you)限公(gong)司成(cheng)立(li)于1997年,于2015年12月成(cheng)為上市企業蘇州(zhou)天華超凈科技(ji)股(gu)份有(you)限公(gong)司(股(gu)票(piao)代碼300390)的全資子(zi)公(gong)司,公(gong)司生產一次性使用(yong)無菌醫(yi)療(liao)器械產品。
公司(si)注(zhu)冊資金6000萬(wan)元,總面積約5萬(wan)平方(fang)米,潔凈車(che)間面積約1.1萬(wan)平方(fang)米。公司(si)產(chan)(chan)(chan)品(pin)依(yi)據醫(yi)療(liao)器械(xie)生(sheng)(sheng)產(chan)(chan)(chan)質(zhi)量管(guan)(guan)理(li)規(gui)范生(sheng)(sheng)產(chan)(chan)(chan),通過(guo)了ISO13485-2016、ISO9001-2015質(zhi)量體系(xi)認(ren)證(zheng),通過(guo)了GB/T28001-2011idtOHSAS18001:2007、GB/T24001-2016idtISO14001:2015職業(ye)健(jian)康安全管(guan)(guan)理(li)體系(xi)和(he)環境管(guan)(guan)理(li)體系(xi)認(ren)證(zheng)。產(chan)(chan)(chan)品(pin)取得(de)歐(ou)盟CE認(ren)證(zheng)、巴西ANVISA GMP認(ren)證(zheng)、美(mei)國(guo)(guo)(guo)(guo)(guo)FDA認(ren)證(zheng)等多個(ge)(ge)國(guo)(guo)(guo)(guo)(guo)家(jia)的認(ren)證(zheng),自毀型一次性使用注(zhu)射(she)器獲得(de)世界(jie)衛生(sheng)(sheng)組(zu)織WHO的認(ren)證(zheng)證(zheng)書(shu)。2014年7月和(he)2017年9月分別“O”缺陷通過(guo)美(mei)國(guo)(guo)(guo)(guo)(guo)FAD現場工廠審核。經過(guo)十多年的建設和(he)發(fa)展(zhan),公司(si)已成(cheng)為(wei)國(guo)(guo)(guo)(guo)(guo)內(nei)較具規(gui)模的一次性醫(yi)療(liao)器械(xie)產(chan)(chan)(chan)品(pin)的研發(fa)、生(sheng)(sheng)產(chan)(chan)(chan)基地。在自毀型一次性使用注(zhu)射(she)器領域(yu)達到了國(guo)(guo)(guo)(guo)(guo)際水平。公司(si)產(chan)(chan)(chan)品(pin)常年出口至美(mei)國(guo)(guo)(guo)(guo)(guo)、德(de)國(guo)(guo)(guo)(guo)(guo)、意(yi)大利、俄羅斯、印度、韓(han)國(guo)(guo)(guo)(guo)(guo)、尼日利亞、菲律賓(bin)等歐(ou)盟、美(mei)洲、非洲、東南亞、中東地區近百個(ge)(ge)國(guo)(guo)(guo)(guo)(guo)家(jia)。國(guo)(guo)(guo)(guo)(guo)內(nei)銷售(shou)覆蓋了三十二個(ge)(ge)省(sheng)、自治區、直轄市(shi)。
公司擁有國內(nei)的生產設(she)備和(he)(he)設(she)施,產品有自毀型(xing)一(yi)(yi)(yi)(yi)次(ci)(ci)性(xing)(xing)(xing)(xing)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)無菌注(zhu)射(she)(she)器(qi)(qi)(qi)(qi)、回縮型(xing)一(yi)(yi)(yi)(yi)次(ci)(ci)性(xing)(xing)(xing)(xing)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)無菌注(zhu)射(she)(she)器(qi)(qi)(qi)(qi)、一(yi)(yi)(yi)(yi)次(ci)(ci)性(xing)(xing)(xing)(xing)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)無菌針(zhen)(zhen)(zhen)罩式(shi)注(zhu)射(she)(she)針(zhen)(zhen)(zhen)(安全注(zhu)射(she)(she)針(zhen)(zhen)(zhen))、一(yi)(yi)(yi)(yi)次(ci)(ci)性(xing)(xing)(xing)(xing)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)無菌針(zhen)(zhen)(zhen)罩式(shi)注(zhu)射(she)(she)器(qi)(qi)(qi)(qi)帶針(zhen)(zhen)(zhen)(安全注(zhu)射(she)(she)器(qi)(qi)(qi)(qi))、一(yi)(yi)(yi)(yi)次(ci)(ci)性(xing)(xing)(xing)(xing)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)無菌注(zhu)射(she)(she)針(zhen)(zhen)(zhen)、一(yi)(yi)(yi)(yi)次(ci)(ci)性(xing)(xing)(xing)(xing)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)無菌注(zhu)射(she)(she)器(qi)(qi)(qi)(qi)帶針(zhen)(zhen)(zhen)(三件(jian)式(shi)、二件(jian)式(shi))、一(yi)(yi)(yi)(yi)次(ci)(ci)性(xing)(xing)(xing)(xing)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)醫(yi)用(yong)(yong)(yong)(yong)口罩、醫(yi)用(yong)(yong)(yong)(yong)外科口罩、一(yi)(yi)(yi)(yi)次(ci)(ci)性(xing)(xing)(xing)(xing)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)輸(shu)(shu)液器(qi)(qi)(qi)(qi)帶針(zhen)(zhen)(zhen)、一(yi)(yi)(yi)(yi)次(ci)(ci)性(xing)(xing)(xing)(xing)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)靜(jing)脈輸(shu)(shu)液針(zhen)(zhen)(zhen)、一(yi)(yi)(yi)(yi)次(ci)(ci)性(xing)(xing)(xing)(xing)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)高壓(ya)注(zhu)射(she)(she)器(qi)(qi)(qi)(qi)及(ji)附件(jian)、一(yi)(yi)(yi)(yi)次(ci)(ci)性(xing)(xing)(xing)(xing)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)胰島(dao)素注(zhu)射(she)(she)器(qi)(qi)(qi)(qi)、一(yi)(yi)(yi)(yi)次(ci)(ci)性(xing)(xing)(xing)(xing)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)注(zhu)射(she)(she)筆用(yong)(yong)(yong)(yong)針(zhen)(zhen)(zhen)頭(諾和(he)(he)筆針(zhen)(zhen)(zhen))、一(yi)(yi)(yi)(yi)次(ci)(ci)性(xing)(xing)(xing)(xing)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)腔鏡(jing)切割吻(wen)合(he)(he)器(qi)(qi)(qi)(qi)及(ji)組(zu)件(jian)、一(yi)(yi)(yi)(yi)次(ci)(ci)性(xing)(xing)(xing)(xing)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)管型(xing)消化(hua)道吻(wen)合(he)(he)器(qi)(qi)(qi)(qi)、一(yi)(yi)(yi)(yi)次(ci)(ci)性(xing)(xing)(xing)(xing)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)肛腸吻(wen)合(he)(he)器(qi)(qi)(qi)(qi)、一(yi)(yi)(yi)(yi)次(ci)(ci)性(xing)(xing)(xing)(xing)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)直線切割吻(wen)(縫(feng))合(he)(he)器(qi)(qi)(qi)(qi)及(ji)組(zu)件(jian)、一(yi)(yi)(yi)(yi)次(ci)(ci)性(xing)(xing)(xing)(xing)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)直線型(xing)吻(wen)(縫(feng))合(he)(he)器(qi)(qi)(qi)(qi)及(ji)組(zu)件(jian)、疝氣補片(pian)(pian)(平(ping)片(pian)(pian)、網(wang)塞)、一(yi)(yi)(yi)(yi)次(ci)(ci)性(xing)(xing)(xing)(xing)使(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)切口保護(hu)套等22個品種。