Kutsha nje, iSanxin Medical extracorporeal circulation pipeline through the United States Food and Drug Administration (FDA) isigunyaziso sentengiso (K202796), le yimveliso yokuqala ye-sanxin yonyango lokucoca igazi efunyenwe isigunyaziso sentengiso se-FDA (510K)!Yimveliso yesihlanu ukufumana i-FDA (510K) isigunyaziso sentengiso emva kwesirinji yokhuseleko yenkampani, isirinji engcolileyo elahlayo, i-IV catheter kunye nemaski yezonyango.I-Sanxin Medical ikwangumvelisi wokuqala wemigca yokujikeleziswa kwe-extracorporeal e-China ukufumana isigunyaziso sentengiso se-FDA (510K), esiquka iindlela zonyango ezininzi ukuhlanjululwa kwegazi (i-hemodialysis, i-hemofiltration, i-hemodiafiltration, i-hemoperfusion, njl.).Okwangoku, kukho abavelisi abangaphantsi kwama-20 bemigca yokujikeleziswa kwe-extracorporeal kwihlabathi jikelele abafumene isigunyaziso sentengiso ye-FDA.

Yasekwa ngo-1997, iSanxin Medical lishishini lesizwe lobuchwepheshe obuphezulu obukhethekileyo kuphando, uphuhliso, ukuvelisa, ukuthengisa kunye nenkonzo yezixhobo zonyango.Emva kweminyaka engama-20 yophuhliso, iSanxin Medical ikhule yaba ngumboneleli okhokelayo wezisombululo ezipheleleyo zehemodialysis eTshayina.Yeyokuqala kwishishini ukuphumelela inkqubo yolawulo lomgangatho we-CE CMD kunye nesiqinisekiso semveliso.Ukuvunywa ngempumelelo kwe-FDA (510K) kuphawula ukuba iimveliso zemibhobho ye-hemodialysis yeSanxin Medical zihambelana nenqanaba lokuqala kwihlabathi, kwaye ikwabubungqina obunamandla bokuba uphawu lwaseTshayina lufumene ufikelelo kwimarike yamazwe ngamazwe kunye nokuqondwa.ISanxin Medical ivule ixesha elitsha lokhuphiswano lwemarike yehlabathi.

I-Sanxin Medical iya kuthatha eli thuba ngokuqhubekayo ukukhawulezisa ipateni yophuhliso lweqhinga lophando lwasekhaya oluzimeleyo kunye nophuhliso kunye nophuhliso lwehlabathi jikelele, igxalaba lenjongo yophuhliso lwezixhobo zonyango lwesizwe, ukukhuthaza iimveliso ezikumgangatho ophezulu kwihlabathi, ukubonelela izigulana ngokukhuselekileyo neziphakamileyo. -imveliso kunye neenkonzo ezisemgangathweni, kwaye negalelo kuphuhliso lwehlabathi jikelele lwezonyango kunye nezempilo.