I tata nei, Sanxin Medical extracorporeal circulation pipeline i roto i te United States Food and Drug Administration (FDA) whakamana hokohoko (K202796), koinei te tuatahi o nga hua raupapa horoi toto hauora sanxin i whiwhi whakamanatanga hokohoko FDA (510K)!Ko te rima o nga hua ki te whiwhi FDA (510K) whakamanatanga hokohoko i muri i te syringe haumaru o te kamupene, syringe horomata tuku, IV catheter me te kanohi hauora.Kua noho ano a Sanxin Medical te kaihanga tuatahi o nga raina tohanga extracorporeal i Haina ki te whiwhi FDA (510K) whakamana hokohoko, e hipoki ana i nga momo maimoatanga maha o te purenga toto (hemodialysis, hemofiltration, hemodiafiltration, hemoperfusion, etc.).I tenei wa, he iti ake i te 20 nga kaihanga o nga raina tohanga extracorporeal puta noa i te ao kua whiwhi whakamanatanga hokohoko FDA.
I whakaturia i te tau 1997, ko Sanxin Medical he hinonga hangarau-nui-a-motu motuhake i roto i te rangahau, te whakawhanaketanga, te hanga, te hoko me te ratonga o nga taputapu rongoa.Whai muri i te 20 tau o te whakawhanaketanga, kua tipu a Sanxin Medical hei kaiwhakarato matua mo nga rongoaa pau mo te hemodialysis i Haina.Ko te tuatahi i roto i te ahumahi ki te tuku i te punaha whakahaere kounga CE CMD me te tiwhikete hua.Ko te whakaaetanga angitu o te FDA(510K) e tohu ana ko nga hua paipa hemodialysis o Sanxin Medical kei te rite ki te taumata tuatahi o te ao, a he kaha ano te whakaatu kua whiwhi te tohu Hainamana ki te maakete o te ao me te mohio.Kua whakatuwherahia e Sanxin Medical tetahi waa hou o te whakataetae maakete o te ao.
Ka whai waahi a Sanxin Medical ki te whakatere tonu i te tauira whanaketanga rautaki o te rangahau motuhake me te whakawhanaketanga o te whare me te whanaketanga tukutahi o te ao, te kawe i te kaupapa o te whanaketanga tohu taputapu rongoa a-motu, te whakatairanga i nga hua o te kounga teitei ki te ao, te whakarato i nga turoro ki te haumaru me te teitei. -Ko nga hua me nga ratonga kounga, me te whai waahi ki te whakawhanaketanga o te kaupapa hauora me te hauora o te ao.
Wā whakairinga: Sep-27-2021