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)(gong)司成立于(yu)(yu)1997年,于(yu)(yu)2015年12月成為上市企業蘇州天華超凈(jing)科技股份有(you)限公(gong)(gong)司(股票(piao)代碼(ma)300390)的全資(zi)子公(gong)(gong)司,公(gong)(gong)司生(sheng)產一次性使用(yong)無菌醫(yi)療(liao)器械產品。
公司注(zhu)冊資金6000萬元,總面積(ji)(ji)約5萬平方(fang)米,潔凈車(che)間(jian)面積(ji)(ji)約1.1萬平方(fang)米。公司產(chan)(chan)(chan)品(pin)依據醫療(liao)器(qi)械(xie)(xie)生產(chan)(chan)(chan)質量管理規范生產(chan)(chan)(chan),通(tong)過了ISO13485-2016、ISO9001-2015質量體系認(ren)證(zheng)(zheng)(zheng),通(tong)過了GB/T28001-2011idtOHSAS18001:2007、GB/T24001-2016idtISO14001:2015職業(ye)健康(kang)安全管理體系和環境管理體系認(ren)證(zheng)(zheng)(zheng)。產(chan)(chan)(chan)品(pin)取得歐(ou)盟CE認(ren)證(zheng)(zheng)(zheng)、巴西ANVISA GMP認(ren)證(zheng)(zheng)(zheng)、美國(guo)(guo)(guo)FDA認(ren)證(zheng)(zheng)(zheng)等多個(ge)國(guo)(guo)(guo)家的認(ren)證(zheng)(zheng)(zheng),自毀型(xing)一(yi)次性(xing)使用注(zhu)射器(qi)獲得世界衛生組(zu)織WHO的認(ren)證(zheng)(zheng)(zheng)證(zheng)(zheng)(zheng)書(shu)。2014年7月(yue)和2017年9月(yue)分別“O”缺陷通(tong)過美國(guo)(guo)(guo)FAD現場工廠審核。經過十(shi)多年的建設和發展(zhan),公司已成為(wei)國(guo)(guo)(guo)內(nei)較(jiao)具規模的一(yi)次性(xing)醫療(liao)器(qi)械(xie)(xie)產(chan)(chan)(chan)品(pin)的研發、生產(chan)(chan)(chan)基地(di)。在自毀型(xing)一(yi)次性(xing)使用注(zhu)射器(qi)領(ling)域達到了國(guo)(guo)(guo)際水平。公司產(chan)(chan)(chan)品(pin)常年出口至美國(guo)(guo)(guo)、德國(guo)(guo)(guo)、意大(da)利、俄羅(luo)斯(si)、印度、韓國(guo)(guo)(guo)、尼(ni)日利亞、菲律賓等歐(ou)盟、美洲、非洲、東南亞、中東地(di)區(qu)近(jin)百(bai)個(ge)國(guo)(guo)(guo)家。國(guo)(guo)(guo)內(nei)銷售覆蓋了三十(shi)二個(ge)省(sheng)、自治區(qu)、直轄市。
公司擁有國內的生產設備和設施,產品有自毀型一(yi)(yi)(yi)(yi)次(ci)(ci)(ci)(ci)(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)無(wu)(wu)菌注射(she)(she)(she)(she)器(qi)(qi)(qi)、回縮型一(yi)(yi)(yi)(yi)次(ci)(ci)(ci)(ci)(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)無(wu)(wu)菌注射(she)(she)(she)(she)器(qi)(qi)(qi)、一(yi)(yi)(yi)(yi)次(ci)(ci)(ci)(ci)(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)無(wu)(wu)菌針(zhen)(zhen)罩(zhao)式注射(she)(she)(she)(she)針(zhen)(zhen)(安全注射(she)(she)(she)(she)針(zhen)(zhen))、一(yi)(yi)(yi)(yi)次(ci)(ci)(ci)(ci)(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)無(wu)(wu)菌針(zhen)(zhen)罩(zhao)式注射(she)(she)(she)(she)器(qi)(qi)(qi)帶針(zhen)(zhen)(安全注射(she)(she)(she)(she)器(qi)(qi)(qi))、一(yi)(yi)(yi)(yi)次(ci)(ci)(ci)(ci)(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)無(wu)(wu)菌注射(she)(she)(she)(she)針(zhen)(zhen)、一(yi)(yi)(yi)(yi)次(ci)(ci)(ci)(ci)(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)無(wu)(wu)菌注射(she)(she)(she)(she)器(qi)(qi)(qi)帶針(zhen)(zhen)(三件(jian)(jian)式、二件(jian)(jian)式)、一(yi)(yi)(yi)(yi)次(ci)(ci)(ci)(ci)(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)醫用(yong)(yong)(yong)(yong)(yong)口罩(zhao)、醫用(yong)(yong)(yong)(yong)(yong)外科口罩(zhao)、一(yi)(yi)(yi)(yi)次(ci)(ci)(ci)(ci)(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)輸液(ye)器(qi)(qi)(qi)帶針(zhen)(zhen)、一(yi)(yi)(yi)(yi)次(ci)(ci)(ci)(ci)(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)靜脈(mo)輸液(ye)針(zhen)(zhen)、一(yi)(yi)(yi)(yi)次(ci)(ci)(ci)(ci)(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)高(gao)壓注射(she)(she)(she)(she)器(qi)(qi)(qi)及(ji)附件(jian)(jian)、一(yi)(yi)(yi)(yi)次(ci)(ci)(ci)(ci)(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)胰島素注射(she)(she)(she)(she)器(qi)(qi)(qi)、一(yi)(yi)(yi)(yi)次(ci)(ci)(ci)(ci)(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)注射(she)(she)(she)(she)筆用(yong)(yong)(yong)(yong)(yong)針(zhen)(zhen)頭(諾和筆針(zhen)(zhen))、一(yi)(yi)(yi)(yi)次(ci)(ci)(ci)(ci)(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)腔鏡切(qie)割吻(wen)合器(qi)(qi)(qi)及(ji)組件(jian)(jian)、一(yi)(yi)(yi)(yi)次(ci)(ci)(ci)(ci)(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)管型消化(hua)道吻(wen)合器(qi)(qi)(qi)、一(yi)(yi)(yi)(yi)次(ci)(ci)(ci)(ci)(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)肛腸(chang)吻(wen)合器(qi)(qi)(qi)、一(yi)(yi)(yi)(yi)次(ci)(ci)(ci)(ci)(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)直(zhi)線切(qie)割吻(wen)(縫)合器(qi)(qi)(qi)及(ji)組件(jian)(jian)、一(yi)(yi)(yi)(yi)次(ci)(ci)(ci)(ci)(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)直(zhi)線型吻(wen)(縫)合器(qi)(qi)(qi)及(ji)組件(jian)(jian)、疝(shan)氣補片(平片、網塞)、一(yi)(yi)(yi)(yi)次(ci)(ci)(ci)(ci)(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)切(qie)口保護(hu)套等22個品種。