Iindaba Ezintsha: Isitulo Esinamavili Esinamandla saseNingbo Baichen Sifumene Isiqinisekiso Esiphezulu se-FDA sase-US – 510K No. K232121!

Iindaba Ezintsha: Isitulo Esinamavili Esinamandla saseNingbo Baichen Sifumene Isiqinisekiso Esiphezulu se-FDA sase-US – 510K No. K232121!

umfanekiso 1

Kwimpumelelo emangalisayo egxininisa ukuzinikela kweNingbo Baichen Medical Devices Co. Ltd kumgangatho ophezulu kunye nokuvelisa izinto ezintsha, inkampaniisitulo esinamavili esisebenza ngamandlariphumelele ukufumana isiqinisekiso esifunwa kakhulu yi-United States Food and Drug Administration (FDA). Eli nyathelo libalulekileyo liphawulwe ngokunikwa i-510K Number K232121, nto leyo ebonisa ukuthobela kwemveliso imigangatho engqongqo ye-FDA.

Ukubaluleka kweSatifikethi se-FDA

Ukufumana isiqinisekiso se-FDA yimpumelelo enkulu kushishino lwezixhobo zonyango, kwaye kubonisa ukuzinikela kweNingbo Baichen ekuhlangabezaneni nasekugqitheni imigangatho ephezulu yomthetho eMelika. I-FDA idume ngenkqubo yayo yokuvavanya ngokungqongqo, eqinisekisa ukuba iimveliso ezingena kwimarike zikhuselekile kwaye ziyasebenza kubathengi.

Ukuzibophelela kukaNingbo Baichen ekuGqweseni

I-Ningbo Baichen Medical Devices Co. Ltd, igama eliphambili kushishino lwezixhobo zonyango, isoloko igxininisa kakhulu kumgangatho, ukhuseleko, kunye nokuvelisa izinto ezintsha. Olu qinisekiso lwakutshanje lubungqina bokuzinikela kwenkampani ngokungagungqiyo ekunikezeleni iimveliso ezikumgangatho ophezulu kubathengi bayo.

Umfanekiso we-2

Malunga neisitulo esinamavili sombane esinefayibha yekhabhoni 

Isitulo esinamavili sikaNingbo Baichen esisebenza ngamandla sisisombululo esiphucukileyo sokuhamba esenzelwe ukuphucula ubomi babantu abaneengxaki zokuhamba. Ngobuchwepheshe obuphambili kunye noyilo olusebenzayo, esi situlo esinamavili asiboneleli nje kuphela ngokuhamba okuphuculweyo kodwa sikwabonelela ngentuthuzelo kunye nokulula kokusetyenziswa.

Indlela Engaphambili

Njengoko i-Ningbo Baichen Medical Devices Co. Ltd inesatifikethi se-FDA esandleni, ikulungele ukwandisa ubukho bayo kwimarike yaseMelika kwaye inikezele ngeenkonzo zayo ezibalaseleyo.Isitulo sabakhubazekileyo esineemotokubaphulaphuli abaninzi. Le nkampani isazinikele ekuphuculeni iteknoloji yezempilo kunye nokuphucula umgangatho wobomi babantu abaneengxaki zokuhamba.

Isiphelo

Impumelelo yeNingbo Baichen Medical Devices Co. Ltd ekufumaneni isiqinisekiso se-FDA se-FDA yayoIsitulo Esinamavili Sokunyamekela Ekhayalinyathelo elibalulekileyo elibonisa ukuzinikela kwayo ekugqweseni. Njengoko besiya phambili, ukuzinikela kwabo ekuveliseni izinto ezintsha kunye nokuqinisekiswa komgangatho kuthembisa impumelelo eqhubekayo kwishishini lezixhobo zonyango.

 

isitulo esinamavili esisebenza ngamandla

 

isitulo esinamavili sombane esinefayibha yekhabhoni

 

Isitulo sabakhubazekileyo esineemoto

 

Isitulo Esinamavili Sokunyamekela Ekhaya

 

 

 


Ixesha lokuthumela: Okthobha-10-2023