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(wu)(wu)錫市宇壽醫(yi)(yi)療(liao)器械有限公司(si)成立于(yu)1997年(nian),于(yu)2015年(nian)12月成為上(shang)市企業蘇州天華超凈科技股份有限公司(si)(股票代碼300390)的(de)全資子公司(si),公司(si)生(sheng)產一次性使用無(wu)(wu)菌醫(yi)(yi)療(liao)器械產品。
公(gong)司(si)(si)注(zhu)冊資(zi)金(jin)6000萬元,總面積約(yue)5萬平方米,潔凈車間面積約(yue)1.1萬平方米。公(gong)司(si)(si)產(chan)品依據醫療器械生(sheng)產(chan)質量管理(li)規范生(sheng)產(chan),通過了ISO13485-2016、ISO9001-2015質量體(ti)系(xi)(xi)認(ren)(ren)(ren)證(zheng),通過了GB/T28001-2011idtOHSAS18001:2007、GB/T24001-2016idtISO14001:2015職業健康安(an)全管理(li)體(ti)系(xi)(xi)和(he)環境管理(li)體(ti)系(xi)(xi)認(ren)(ren)(ren)證(zheng)。產(chan)品取得歐(ou)盟CE認(ren)(ren)(ren)證(zheng)、巴西ANVISA GMP認(ren)(ren)(ren)證(zheng)、美國(guo)(guo)FDA認(ren)(ren)(ren)證(zheng)等多個國(guo)(guo)家(jia)的認(ren)(ren)(ren)證(zheng),自毀(hui)型一次(ci)(ci)性使用注(zhu)射器獲得世界衛(wei)生(sheng)組織WHO的認(ren)(ren)(ren)證(zheng)證(zheng)書。2014年(nian)7月(yue)和(he)2017年(nian)9月(yue)分別(bie)“O”缺陷通過美國(guo)(guo)FAD現場工(gong)廠審核(he)。經(jing)過十多年(nian)的建設和(he)發展,公(gong)司(si)(si)已成為國(guo)(guo)內(nei)較(jiao)具規模的一次(ci)(ci)性醫療器械產(chan)品的研發、生(sheng)產(chan)基(ji)地。在自毀(hui)型一次(ci)(ci)性使用注(zhu)射器領(ling)域達到了國(guo)(guo)際水平。公(gong)司(si)(si)產(chan)品常年(nian)出口至美國(guo)(guo)、德國(guo)(guo)、意大利(li)、俄羅斯、印度(du)、韓國(guo)(guo)、尼日利(li)亞、菲律賓(bin)等歐(ou)盟、美洲(zhou)、非洲(zhou)、東南亞、中東地區近百(bai)個國(guo)(guo)家(jia)。國(guo)(guo)內(nei)銷售覆蓋了三十二個省、自治區、直轄市。
公司擁有國內的(de)生(sheng)產設備和(he)(he)設施,產品有自毀型(xing)一(yi)(yi)(yi)(yi)(yi)次(ci)性(xing)(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)無(wu)(wu)(wu)菌(jun)注(zhu)(zhu)射器(qi)(qi)(qi)(qi)(qi)、回(hui)縮型(xing)一(yi)(yi)(yi)(yi)(yi)次(ci)性(xing)(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)無(wu)(wu)(wu)菌(jun)注(zhu)(zhu)射器(qi)(qi)(qi)(qi)(qi)、一(yi)(yi)(yi)(yi)(yi)次(ci)性(xing)(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)無(wu)(wu)(wu)菌(jun)針(zhen)(zhen)(zhen)(zhen)(zhen)罩式(shi)(shi)注(zhu)(zhu)射針(zhen)(zhen)(zhen)(zhen)(zhen)(安全注(zhu)(zhu)射針(zhen)(zhen)(zhen)(zhen)(zhen))、一(yi)(yi)(yi)(yi)(yi)次(ci)性(xing)(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)無(wu)(wu)(wu)菌(jun)針(zhen)(zhen)(zhen)(zhen)(zhen)罩式(shi)(shi)注(zhu)(zhu)射器(qi)(qi)(qi)(qi)(qi)帶針(zhen)(zhen)(zhen)(zhen)(zhen)(安全注(zhu)(zhu)射器(qi)(qi)(qi)(qi)(qi))、一(yi)(yi)(yi)(yi)(yi)次(ci)性(xing)(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)無(wu)(wu)(wu)菌(jun)注(zhu)(zhu)射針(zhen)(zhen)(zhen)(zhen)(zhen)、一(yi)(yi)(yi)(yi)(yi)次(ci)性(xing)(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)無(wu)(wu)(wu)菌(jun)注(zhu)(zhu)射器(qi)(qi)(qi)(qi)(qi)帶針(zhen)(zhen)(zhen)(zhen)(zhen)(三件(jian)式(shi)(shi)、二件(jian)式(shi)(shi))、一(yi)(yi)(yi)(yi)(yi)次(ci)性(xing)(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)醫用(yong)(yong)(yong)(yong)(yong)(yong)口(kou)罩、醫用(yong)(yong)(yong)(yong)(yong)(yong)外科口(kou)罩、一(yi)(yi)(yi)(yi)(yi)次(ci)性(xing)(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)輸液(ye)器(qi)(qi)(qi)(qi)(qi)帶針(zhen)(zhen)(zhen)(zhen)(zhen)、一(yi)(yi)(yi)(yi)(yi)次(ci)性(xing)(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)靜脈輸液(ye)針(zhen)(zhen)(zhen)(zhen)(zhen)、一(yi)(yi)(yi)(yi)(yi)次(ci)性(xing)(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)高壓注(zhu)(zhu)射器(qi)(qi)(qi)(qi)(qi)及(ji)附件(jian)、一(yi)(yi)(yi)(yi)(yi)次(ci)性(xing)(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)胰島(dao)素(su)注(zhu)(zhu)射器(qi)(qi)(qi)(qi)(qi)、一(yi)(yi)(yi)(yi)(yi)次(ci)性(xing)(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)注(zhu)(zhu)射筆用(yong)(yong)(yong)(yong)(yong)(yong)針(zhen)(zhen)(zhen)(zhen)(zhen)頭(諾和(he)(he)筆針(zhen)(zhen)(zhen)(zhen)(zhen))、一(yi)(yi)(yi)(yi)(yi)次(ci)性(xing)(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)腔鏡切割吻合(he)器(qi)(qi)(qi)(qi)(qi)及(ji)組件(jian)、一(yi)(yi)(yi)(yi)(yi)次(ci)性(xing)(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)管型(xing)消(xiao)化道吻合(he)器(qi)(qi)(qi)(qi)(qi)、一(yi)(yi)(yi)(yi)(yi)次(ci)性(xing)(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)肛腸吻合(he)器(qi)(qi)(qi)(qi)(qi)、一(yi)(yi)(yi)(yi)(yi)次(ci)性(xing)(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)直(zhi)線切割吻(縫(feng))合(he)器(qi)(qi)(qi)(qi)(qi)及(ji)組件(jian)、一(yi)(yi)(yi)(yi)(yi)次(ci)性(xing)(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)直(zhi)線型(xing)吻(縫(feng))合(he)器(qi)(qi)(qi)(qi)(qi)及(ji)組件(jian)、疝氣補片(pian)(平片(pian)、網塞(sai))、一(yi)(yi)(yi)(yi)(yi)次(ci)性(xing)(xing)(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)切口(kou)保護套等22個(ge)品種。