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)療器械有限(xian)公司成立于(yu)1997年,于(yu)2015年12月成為上市企業蘇州天華超(chao)凈(jing)科技股(gu)份(fen)有限(xian)公司(股(gu)票(piao)代碼(ma)300390)的(de)全資子公司,公司生產(chan)一次性使用無菌醫(yi)療器械產(chan)品。
公司(si)注冊資金6000萬(wan)元,總(zong)面積約5萬(wan)平(ping)方(fang)米,潔凈車(che)間面積約1.1萬(wan)平(ping)方(fang)米。公司(si)產(chan)(chan)品(pin)依據(ju)醫療器(qi)械生產(chan)(chan)質(zhi)量管理規范生產(chan)(chan),通(tong)過了ISO13485-2016、ISO9001-2015質(zhi)量體(ti)(ti)系(xi)認(ren)證(zheng)(zheng),通(tong)過了GB/T28001-2011idtOHSAS18001:2007、GB/T24001-2016idtISO14001:2015職(zhi)業(ye)健康安全(quan)管理體(ti)(ti)系(xi)和環境管理體(ti)(ti)系(xi)認(ren)證(zheng)(zheng)。產(chan)(chan)品(pin)取(qu)得(de)歐盟(meng)CE認(ren)證(zheng)(zheng)、巴西ANVISA GMP認(ren)證(zheng)(zheng)、美(mei)國(guo)FDA認(ren)證(zheng)(zheng)等多個(ge)國(guo)家(jia)的(de)(de)認(ren)證(zheng)(zheng),自毀型一次性(xing)使(shi)用(yong)(yong)注射(she)器(qi)獲(huo)得(de)世界衛(wei)生組織WHO的(de)(de)認(ren)證(zheng)(zheng)證(zheng)(zheng)書。2014年(nian)(nian)7月(yue)(yue)和2017年(nian)(nian)9月(yue)(yue)分別“O”缺陷通(tong)過美(mei)國(guo)FAD現場(chang)工廠審核。經過十(shi)多年(nian)(nian)的(de)(de)建設和發展(zhan),公司(si)已成(cheng)為國(guo)內(nei)較具規模(mo)的(de)(de)一次性(xing)醫療器(qi)械產(chan)(chan)品(pin)的(de)(de)研發、生產(chan)(chan)基地。在自毀型一次性(xing)使(shi)用(yong)(yong)注射(she)器(qi)領域達到了國(guo)際水平(ping)。公司(si)產(chan)(chan)品(pin)常年(nian)(nian)出(chu)口至美(mei)國(guo)、德國(guo)、意(yi)大利、俄羅斯、印度、韓國(guo)、尼日利亞、菲律賓等歐盟(meng)、美(mei)洲、非(fei)洲、東南亞、中東地區近百個(ge)國(guo)家(jia)。國(guo)內(nei)銷售覆蓋(gai)了三十(shi)二個(ge)省(sheng)、自治區、直(zhi)轄市。
公司擁有國內的生產(chan)設備(bei)和設施,產(chan)品有自毀型(xing)一(yi)(yi)次(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)使(shi)(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)無(wu)(wu)菌(jun)(jun)注(zhu)(zhu)(zhu)(zhu)射(she)(she)器(qi)(qi)、回縮型(xing)一(yi)(yi)次(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)使(shi)(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)無(wu)(wu)菌(jun)(jun)注(zhu)(zhu)(zhu)(zhu)射(she)(she)器(qi)(qi)、一(yi)(yi)次(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)使(shi)(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)無(wu)(wu)菌(jun)(jun)針(zhen)(zhen)罩(zhao)式(shi)注(zhu)(zhu)(zhu)(zhu)射(she)(she)針(zhen)(zhen)(安(an)全注(zhu)(zhu)(zhu)(zhu)射(she)(she)針(zhen)(zhen))、一(yi)(yi)次(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)使(shi)(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)無(wu)(wu)菌(jun)(jun)針(zhen)(zhen)罩(zhao)式(shi)注(zhu)(zhu)(zhu)(zhu)射(she)(she)器(qi)(qi)帶針(zhen)(zhen)(安(an)全注(zhu)(zhu)(zhu)(zhu)射(she)(she)器(qi)(qi))、一(yi)(yi)次(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)使(shi)(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)無(wu)(wu)菌(jun)(jun)注(zhu)(zhu)(zhu)(zhu)射(she)(she)針(zhen)(zhen)、一(yi)(yi)次(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)使(shi)(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)無(wu)(wu)菌(jun)(jun)注(zhu)(zhu)(zhu)(zhu)射(she)(she)器(qi)(qi)帶針(zhen)(zhen)(三件(jian)式(shi)、二件(jian)式(shi))、一(yi)(yi)次(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)使(shi)(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)醫用(yong)(yong)(yong)(yong)(yong)(yong)口(kou)罩(zhao)、醫用(yong)(yong)(yong)(yong)(yong)(yong)外科口(kou)罩(zhao)、一(yi)(yi)次(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)使(shi)(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)輸液器(qi)(qi)帶針(zhen)(zhen)、一(yi)(yi)次(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)使(shi)(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)靜脈輸液針(zhen)(zhen)、一(yi)(yi)次(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)使(shi)(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)高(gao)壓注(zhu)(zhu)(zhu)(zhu)射(she)(she)器(qi)(qi)及附件(jian)、一(yi)(yi)次(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)使(shi)(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)胰島(dao)素(su)注(zhu)(zhu)(zhu)(zhu)射(she)(she)器(qi)(qi)、一(yi)(yi)次(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)使(shi)(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)注(zhu)(zhu)(zhu)(zhu)射(she)(she)筆用(yong)(yong)(yong)(yong)(yong)(yong)針(zhen)(zhen)頭(諾和筆針(zhen)(zhen))、一(yi)(yi)次(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)使(shi)(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)腔鏡(jing)切割吻合(he)器(qi)(qi)及組件(jian)、一(yi)(yi)次(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)使(shi)(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)管(guan)型(xing)消(xiao)化道吻合(he)器(qi)(qi)、一(yi)(yi)次(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)使(shi)(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)肛腸吻合(he)器(qi)(qi)、一(yi)(yi)次(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)使(shi)(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)直線切割吻(縫(feng)(feng))合(he)器(qi)(qi)及組件(jian)、一(yi)(yi)次(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)使(shi)(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)直線型(xing)吻(縫(feng)(feng))合(he)器(qi)(qi)及組件(jian)、疝氣補(bu)片(平片、網塞)、一(yi)(yi)次(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)使(shi)(shi)(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)切口(kou)保護套等22個品種。