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)錫(xi)市宇壽醫(yi)療器(qi)械(xie)有(you)限公(gong)司成立于(yu)1997年,于(yu)2015年12月(yue)成為上市企業蘇州天華(hua)超凈科技股(gu)份(fen)有(you)限公(gong)司(股(gu)票代碼300390)的全資子公(gong)司,公(gong)司生(sheng)產(chan)(chan)一次(ci)性(xing)使用無(wu)菌醫(yi)療器(qi)械(xie)產(chan)(chan)品。
公司注冊(ce)資金6000萬元,總面積約5萬平(ping)方(fang)米,潔(jie)凈車間面積約1.1萬平(ping)方(fang)米。公司產(chan)品依據醫療(liao)器(qi)械生產(chan)質(zhi)量管(guan)理規(gui)范生產(chan),通(tong)(tong)過了ISO13485-2016、ISO9001-2015質(zhi)量體(ti)(ti)(ti)系認(ren)(ren)證(zheng)(zheng),通(tong)(tong)過了GB/T28001-2011idtOHSAS18001:2007、GB/T24001-2016idtISO14001:2015職業健(jian)康安(an)全(quan)管(guan)理體(ti)(ti)(ti)系和(he)環境管(guan)理體(ti)(ti)(ti)系認(ren)(ren)證(zheng)(zheng)。產(chan)品取(qu)得歐盟CE認(ren)(ren)證(zheng)(zheng)、巴西ANVISA GMP認(ren)(ren)證(zheng)(zheng)、美(mei)國(guo)FDA認(ren)(ren)證(zheng)(zheng)等多個(ge)國(guo)家的認(ren)(ren)證(zheng)(zheng),自毀(hui)型一(yi)(yi)次(ci)性使(shi)用(yong)注射器(qi)獲得世界衛生組(zu)織WHO的認(ren)(ren)證(zheng)(zheng)證(zheng)(zheng)書。2014年7月(yue)和(he)2017年9月(yue)分別(bie)“O”缺陷通(tong)(tong)過美(mei)國(guo)FAD現(xian)場工(gong)廠(chang)審核(he)。經(jing)過十(shi)多年的建設和(he)發(fa)展,公司已成(cheng)為國(guo)內較具規(gui)模的一(yi)(yi)次(ci)性醫療(liao)器(qi)械產(chan)品的研發(fa)、生產(chan)基地。在自毀(hui)型一(yi)(yi)次(ci)性使(shi)用(yong)注射器(qi)領域達到(dao)了國(guo)際水(shui)平(ping)。公司產(chan)品常年出口至美(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、美(mei)洲、非(fei)洲、東南亞、中(zhong)東地區近百個(ge)國(guo)家。國(guo)內銷售覆蓋了三十(shi)二個(ge)省、自治區、直(zhi)轄市。
公司擁(yong)有國內的生產設(she)(she)備和(he)設(she)(she)施,產品有自毀型一(yi)(yi)(yi)(yi)次(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)(yong)無(wu)菌(jun)注(zhu)(zhu)射(she)(she)器(qi)(qi)(qi)(qi)(qi)(qi)、回縮型一(yi)(yi)(yi)(yi)次(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)(yong)無(wu)菌(jun)注(zhu)(zhu)射(she)(she)器(qi)(qi)(qi)(qi)(qi)(qi)、一(yi)(yi)(yi)(yi)次(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)(yong)無(wu)菌(jun)針(zhen)(zhen)罩(zhao)式(shi)注(zhu)(zhu)射(she)(she)針(zhen)(zhen)(安全(quan)注(zhu)(zhu)射(she)(she)針(zhen)(zhen))、一(yi)(yi)(yi)(yi)次(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)(yong)無(wu)菌(jun)針(zhen)(zhen)罩(zhao)式(shi)注(zhu)(zhu)射(she)(she)器(qi)(qi)(qi)(qi)(qi)(qi)帶(dai)(dai)(dai)針(zhen)(zhen)(安全(quan)注(zhu)(zhu)射(she)(she)器(qi)(qi)(qi)(qi)(qi)(qi))、一(yi)(yi)(yi)(yi)次(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)(yong)無(wu)菌(jun)注(zhu)(zhu)射(she)(she)針(zhen)(zhen)、一(yi)(yi)(yi)(yi)次(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)(yong)無(wu)菌(jun)注(zhu)(zhu)射(she)(she)器(qi)(qi)(qi)(qi)(qi)(qi)帶(dai)(dai)(dai)針(zhen)(zhen)(三(san)件式(shi)、二件式(shi))、一(yi)(yi)(yi)(yi)次(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)(yong)醫用(yong)(yong)(yong)(yong)(yong)(yong)(yong)口(kou)(kou)罩(zhao)、醫用(yong)(yong)(yong)(yong)(yong)(yong)(yong)外科(ke)口(kou)(kou)罩(zhao)、一(yi)(yi)(yi)(yi)次(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)(yong)輸液器(qi)(qi)(qi)(qi)(qi)(qi)帶(dai)(dai)(dai)針(zhen)(zhen)、一(yi)(yi)(yi)(yi)次(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)(yong)靜脈輸液針(zhen)(zhen)、一(yi)(yi)(yi)(yi)次(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)(yong)高壓注(zhu)(zhu)射(she)(she)器(qi)(qi)(qi)(qi)(qi)(qi)及(ji)附件、一(yi)(yi)(yi)(yi)次(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)(yong)胰島(dao)素注(zhu)(zhu)射(she)(she)器(qi)(qi)(qi)(qi)(qi)(qi)、一(yi)(yi)(yi)(yi)次(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)(yong)注(zhu)(zhu)射(she)(she)筆(bi)用(yong)(yong)(yong)(yong)(yong)(yong)(yong)針(zhen)(zhen)頭(諾和(he)筆(bi)針(zhen)(zhen))、一(yi)(yi)(yi)(yi)次(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)(yong)腔鏡切割(ge)(ge)吻(wen)(wen)合(he)(he)器(qi)(qi)(qi)(qi)(qi)(qi)及(ji)組件、一(yi)(yi)(yi)(yi)次(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)(yong)管(guan)型消(xiao)化道(dao)吻(wen)(wen)合(he)(he)器(qi)(qi)(qi)(qi)(qi)(qi)、一(yi)(yi)(yi)(yi)次(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)(yong)肛腸吻(wen)(wen)合(he)(he)器(qi)(qi)(qi)(qi)(qi)(qi)、一(yi)(yi)(yi)(yi)次(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)(yong)直線切割(ge)(ge)吻(wen)(wen)(縫(feng))合(he)(he)器(qi)(qi)(qi)(qi)(qi)(qi)及(ji)組件、一(yi)(yi)(yi)(yi)次(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)(yong)直線型吻(wen)(wen)(縫(feng))合(he)(he)器(qi)(qi)(qi)(qi)(qi)(qi)及(ji)組件、疝氣補片(平片、網(wang)塞)、一(yi)(yi)(yi)(yi)次(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)使(shi)(shi)(shi)用(yong)(yong)(yong)(yong)(yong)(yong)(yong)切口(kou)(kou)保護套等22個品種(zhong)。