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
無錫市宇壽醫療器(qi)械有(you)(you)限(xian)公(gong)司(si)(si)成立于1997年,于2015年12月成為上(shang)市企業蘇州天(tian)華(hua)超凈科技股份有(you)(you)限(xian)公(gong)司(si)(si)(股票(piao)代碼(ma)300390)的(de)全資(zi)子公(gong)司(si)(si),公(gong)司(si)(si)生產一次性使用無菌醫療器(qi)械產品。
公(gong)司(si)(si)注(zhu)(zhu)冊(ce)資金6000萬(wan)元,總面積(ji)約5萬(wan)平方米(mi),潔(jie)凈車間面積(ji)約1.1萬(wan)平方米(mi)。公(gong)司(si)(si)產品依據醫療器(qi)(qi)械(xie)(xie)生(sheng)產質量管(guan)理(li)規(gui)范生(sheng)產,通(tong)(tong)過了(le)(le)ISO13485-2016、ISO9001-2015質量體系認(ren)(ren)(ren)證(zheng)(zheng)(zheng),通(tong)(tong)過了(le)(le)GB/T28001-2011idtOHSAS18001:2007、GB/T24001-2016idtISO14001:2015職業健(jian)康(kang)安全管(guan)理(li)體系和環(huan)境管(guan)理(li)體系認(ren)(ren)(ren)證(zheng)(zheng)(zheng)。產品取得歐盟(meng)CE認(ren)(ren)(ren)證(zheng)(zheng)(zheng)、巴西ANVISA GMP認(ren)(ren)(ren)證(zheng)(zheng)(zheng)、美國FDA認(ren)(ren)(ren)證(zheng)(zheng)(zheng)等多個(ge)(ge)國家的認(ren)(ren)(ren)證(zheng)(zheng)(zheng),自毀(hui)型(xing)一次(ci)性使用注(zhu)(zhu)射器(qi)(qi)獲得世界衛生(sheng)組(zu)織WHO的認(ren)(ren)(ren)證(zheng)(zheng)(zheng)證(zheng)(zheng)(zheng)書。2014年7月和2017年9月分別“O”缺陷通(tong)(tong)過美國FAD現場工廠(chang)審核。經過十多年的建設和發展,公(gong)司(si)(si)已成為國內(nei)較具規(gui)模的一次(ci)性醫療器(qi)(qi)械(xie)(xie)產品的研(yan)發、生(sheng)產基地。在自毀(hui)型(xing)一次(ci)性使用注(zhu)(zhu)射器(qi)(qi)領域達(da)到了(le)(le)國際水平。公(gong)司(si)(si)產品常(chang)年出口至美國、德國、意大利(li)、俄羅斯、印(yin)度(du)、韓(han)國、尼日利(li)亞、菲律賓等歐盟(meng)、美洲(zhou)、非(fei)洲(zhou)、東南亞、中東地區近百(bai)個(ge)(ge)國家。國內(nei)銷售覆蓋了(le)(le)三十二個(ge)(ge)省、自治區、直轄市。
公(gong)司擁有國內的生產(chan)設備和(he)設施(shi),產(chan)品(pin)有自(zi)毀型(xing)一(yi)(yi)(yi)(yi)次(ci)性(xing)(xing)(xing)使(shi)(shi)(shi)(shi)(shi)(shi)(shi)(shi)用(yong)(yong)(yong)無(wu)(wu)菌(jun)注射器(qi)(qi)、回(hui)縮型(xing)一(yi)(yi)(yi)(yi)次(ci)性(xing)(xing)(xing)使(shi)(shi)(shi)(shi)(shi)(shi)(shi)(shi)用(yong)(yong)(yong)無(wu)(wu)菌(jun)注射器(qi)(qi)、一(yi)(yi)(yi)(yi)次(ci)性(xing)(xing)(xing)使(shi)(shi)(shi)(shi)(shi)(shi)(shi)(shi)用(yong)(yong)(yong)無(wu)(wu)菌(jun)針(zhen)(zhen)罩(zhao)式注射針(zhen)(zhen)(安全注射針(zhen)(zhen))、一(yi)(yi)(yi)(yi)次(ci)性(xing)(xing)(xing)使(shi)(shi)(shi)(shi)(shi)(shi)(shi)(shi)用(yong)(yong)(yong)無(wu)(wu)菌(jun)針(zhen)(zhen)罩(zhao)式注射器(qi)(qi)帶(dai)針(zhen)(zhen)(安全注射器(qi)(qi))、一(yi)(yi)(yi)(yi)次(ci)性(xing)(xing)(xing)使(shi)(shi)(shi)(shi)(shi)(shi)(shi)(shi)用(yong)(yong)(yong)無(wu)(wu)菌(jun)注射針(zhen)(zhen)、一(yi)(yi)(yi)(yi)次(ci)性(xing)(xing)(xing)使(shi)(shi)(shi)(shi)(shi)(shi)(shi)(shi)用(yong)(yong)(yong)無(wu)(wu)菌(jun)注射器(qi)(qi)帶(dai)針(zhen)(zhen)(三件(jian)(jian)式、二件(jian)(jian)式)、一(yi)(yi)(yi)(yi)次(ci)性(xing)(xing)(xing)使(shi)(shi)(shi)(shi)(shi)(shi)(shi)(shi)用(yong)(yong)(yong)醫用(yong)(yong)(yong)口(kou)罩(zhao)、醫用(yong)(yong)(yong)外科口(kou)罩(zhao)、一(yi)(yi)(yi)(yi)次(ci)性(xing)(xing)(xing)使(shi)(shi)(shi)(shi)(shi)(shi)(shi)(shi)用(yong)(yong)(yong)輸液器(qi)(qi)帶(dai)針(zhen)(zhen)、一(yi)(yi)(yi)(yi)次(ci)性(xing)(xing)(xing)使(shi)(shi)(shi)(shi)(shi)(shi)(shi)(shi)用(yong)(yong)(yong)靜脈輸液針(zhen)(zhen)、一(yi)(yi)(yi)(yi)次(ci)性(xing)(xing)(xing)使(shi)(shi)(shi)(shi)(shi)(shi)(shi)(shi)用(yong)(yong)(yong)高(gao)壓(ya)注射器(qi)(qi)及(ji)(ji)附件(jian)(jian)、一(yi)(yi)(yi)(yi)次(ci)性(xing)(xing)(xing)使(shi)(shi)(shi)(shi)(shi)(shi)(shi)(shi)用(yong)(yong)(yong)胰島素注射器(qi)(qi)、一(yi)(yi)(yi)(yi)次(ci)性(xing)(xing)(xing)使(shi)(shi)(shi)(shi)(shi)(shi)(shi)(shi)用(yong)(yong)(yong)注射筆用(yong)(yong)(yong)針(zhen)(zhen)頭(諾(nuo)和(he)筆針(zhen)(zhen))、一(yi)(yi)(yi)(yi)次(ci)性(xing)(xing)(xing)使(shi)(shi)(shi)(shi)(shi)(shi)(shi)(shi)用(yong)(yong)(yong)腔鏡切割吻合(he)器(qi)(qi)及(ji)(ji)組(zu)件(jian)(jian)、一(yi)(yi)(yi)(yi)次(ci)性(xing)(xing)(xing)使(shi)(shi)(shi)(shi)(shi)(shi)(shi)(shi)用(yong)(yong)(yong)管型(xing)消(xiao)化道吻合(he)器(qi)(qi)、一(yi)(yi)(yi)(yi)次(ci)性(xing)(xing)(xing)使(shi)(shi)(shi)(shi)(shi)(shi)(shi)(shi)用(yong)(yong)(yong)肛(gang)腸吻合(he)器(qi)(qi)、一(yi)(yi)(yi)(yi)次(ci)性(xing)(xing)(xing)使(shi)(shi)(shi)(shi)(shi)(shi)(shi)(shi)用(yong)(yong)(yong)直線切割吻(縫)合(he)器(qi)(qi)及(ji)(ji)組(zu)件(jian)(jian)、一(yi)(yi)(yi)(yi)次(ci)性(xing)(xing)(xing)使(shi)(shi)(shi)(shi)(shi)(shi)(shi)(shi)用(yong)(yong)(yong)直線型(xing)吻(縫)合(he)器(qi)(qi)及(ji)(ji)組(zu)件(jian)(jian)、疝氣補片(平(ping)片、網塞)、一(yi)(yi)(yi)(yi)次(ci)性(xing)(xing)(xing)使(shi)(shi)(shi)(shi)(shi)(shi)(shi)(shi)用(yong)(yong)(yong)切口(kou)保護套(tao)等22個(ge)品(pin)種。