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(xi)市宇壽醫療器(qi)械有限(xian)(xian)公(gong)(gong)司(si)(si)(si)成(cheng)立(li)于1997年,于2015年12月成(cheng)為上市企業蘇州(zhou)天華超凈科技股份有限(xian)(xian)公(gong)(gong)司(si)(si)(si)(股票代(dai)碼(ma)300390)的全資子(zi)公(gong)(gong)司(si)(si)(si),公(gong)(gong)司(si)(si)(si)生產(chan)一(yi)次性使用無菌醫療器(qi)械產(chan)品。
公(gong)(gong)司(si)(si)(si)注冊(ce)資(zi)金6000萬元,總面(mian)積約(yue)5萬平(ping)(ping)(ping)方米(mi),潔凈車間面(mian)積約(yue)1.1萬平(ping)(ping)(ping)方米(mi)。公(gong)(gong)司(si)(si)(si)產(chan)(chan)品依據醫療器(qi)(qi)械生(sheng)產(chan)(chan)質量管(guan)理(li)規范生(sheng)產(chan)(chan),通過了(le)(le)ISO13485-2016、ISO9001-2015質量體(ti)系(xi)認證(zheng),通過了(le)(le)GB/T28001-2011idtOHSAS18001:2007、GB/T24001-2016idtISO14001:2015職業健(jian)康安全管(guan)理(li)體(ti)系(xi)和環境管(guan)理(li)體(ti)系(xi)認證(zheng)。產(chan)(chan)品取(qu)得歐(ou)盟CE認證(zheng)、巴西ANVISA GMP認證(zheng)、美(mei)(mei)國FDA認證(zheng)等多個國家的認證(zheng),自毀型(xing)一次(ci)性使(shi)用注射器(qi)(qi)獲(huo)得世界衛生(sheng)組織WHO的認證(zheng)證(zheng)書(shu)。2014年(nian)7月和2017年(nian)9月分別(bie)“O”缺陷通過美(mei)(mei)國FAD現(xian)場(chang)工廠審(shen)核(he)。經過十多年(nian)的建設和發(fa)展,公(gong)(gong)司(si)(si)(si)已成(cheng)為國內(nei)較具規模(mo)的一次(ci)性醫療器(qi)(qi)械產(chan)(chan)品的研(yan)發(fa)、生(sheng)產(chan)(chan)基地(di)。在自毀型(xing)一次(ci)性使(shi)用注射器(qi)(qi)領域達到了(le)(le)國際(ji)水平(ping)(ping)(ping)。公(gong)(gong)司(si)(si)(si)產(chan)(chan)品常(chang)年(nian)出口至美(mei)(mei)國、德國、意大利、俄羅斯、印度、韓國、尼日利亞、菲律賓等歐(ou)盟、美(mei)(mei)洲、非洲、東南亞、中東地(di)區(qu)近百(bai)個國家。國內(nei)銷(xiao)售覆蓋了(le)(le)三十二個省、自治(zhi)區(qu)、直轄市。
公司擁有國內的生產(chan)設備和(he)設施,產(chan)品有自毀型一(yi)(yi)(yi)(yi)(yi)(yi)(yi)(yi)次(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)無(wu)(wu)(wu)菌(jun)注(zhu)(zhu)射(she)器(qi)、回縮型一(yi)(yi)(yi)(yi)(yi)(yi)(yi)(yi)次(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)無(wu)(wu)(wu)菌(jun)注(zhu)(zhu)射(she)器(qi)、一(yi)(yi)(yi)(yi)(yi)(yi)(yi)(yi)次(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)無(wu)(wu)(wu)菌(jun)針(zhen)(zhen)(zhen)罩式(shi)(shi)注(zhu)(zhu)射(she)針(zhen)(zhen)(zhen)(安全注(zhu)(zhu)射(she)針(zhen)(zhen)(zhen))、一(yi)(yi)(yi)(yi)(yi)(yi)(yi)(yi)次(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)無(wu)(wu)(wu)菌(jun)針(zhen)(zhen)(zhen)罩式(shi)(shi)注(zhu)(zhu)射(she)器(qi)帶(dai)針(zhen)(zhen)(zhen)(安全注(zhu)(zhu)射(she)器(qi))、一(yi)(yi)(yi)(yi)(yi)(yi)(yi)(yi)次(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)無(wu)(wu)(wu)菌(jun)注(zhu)(zhu)射(she)針(zhen)(zhen)(zhen)、一(yi)(yi)(yi)(yi)(yi)(yi)(yi)(yi)次(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)無(wu)(wu)(wu)菌(jun)注(zhu)(zhu)射(she)器(qi)帶(dai)針(zhen)(zhen)(zhen)(三件(jian)(jian)式(shi)(shi)、二件(jian)(jian)式(shi)(shi))、一(yi)(yi)(yi)(yi)(yi)(yi)(yi)(yi)次(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)醫用(yong)(yong)(yong)(yong)(yong)口罩、醫用(yong)(yong)(yong)(yong)(yong)外科口罩、一(yi)(yi)(yi)(yi)(yi)(yi)(yi)(yi)次(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)輸(shu)液器(qi)帶(dai)針(zhen)(zhen)(zhen)、一(yi)(yi)(yi)(yi)(yi)(yi)(yi)(yi)次(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)靜(jing)脈輸(shu)液針(zhen)(zhen)(zhen)、一(yi)(yi)(yi)(yi)(yi)(yi)(yi)(yi)次(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)高壓注(zhu)(zhu)射(she)器(qi)及附件(jian)(jian)、一(yi)(yi)(yi)(yi)(yi)(yi)(yi)(yi)次(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)胰島素注(zhu)(zhu)射(she)器(qi)、一(yi)(yi)(yi)(yi)(yi)(yi)(yi)(yi)次(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)注(zhu)(zhu)射(she)筆用(yong)(yong)(yong)(yong)(yong)針(zhen)(zhen)(zhen)頭(tou)(諾和(he)筆針(zhen)(zhen)(zhen))、一(yi)(yi)(yi)(yi)(yi)(yi)(yi)(yi)次(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)腔鏡切(qie)割吻(wen)(wen)合器(qi)及組(zu)件(jian)(jian)、一(yi)(yi)(yi)(yi)(yi)(yi)(yi)(yi)次(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)管型消(xiao)化道(dao)吻(wen)(wen)合器(qi)、一(yi)(yi)(yi)(yi)(yi)(yi)(yi)(yi)次(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)肛腸吻(wen)(wen)合器(qi)、一(yi)(yi)(yi)(yi)(yi)(yi)(yi)(yi)次(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)直線切(qie)割吻(wen)(wen)(縫(feng))合器(qi)及組(zu)件(jian)(jian)、一(yi)(yi)(yi)(yi)(yi)(yi)(yi)(yi)次(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)直線型吻(wen)(wen)(縫(feng))合器(qi)及組(zu)件(jian)(jian)、疝(shan)氣補片(平片、網塞)、一(yi)(yi)(yi)(yi)(yi)(yi)(yi)(yi)次(ci)(ci)(ci)性(xing)(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。