Izindaba Ezisematheni: Isihlalo Esinamasondo Samandla sika-Ningbo Baichen Sizuza Isitifiketi Se-FDA Esihlonishwayo sase-US – 510K No. K232121!

Isiqephu 1

Empumelelweni emangalisayo egcizelela ukuzibophezela kwe-Ningbo Baichen Medical Devices Co. Ltd kwikhwalithi nokusungula izinto ezintsha, inkampaniisihlalo samasondo samandlarizuze ngempumelelo isitifiketi ebesifunwa kakhulu esivela kwa-United States Food and Drug Administration (FDA).Lesi senzakalo esiyingqopha-mlando simakwe ngokuklonyeliswa kweNombolo engu-510K K232121, okubonisa ukuhambisana komkhiqizo nezindinganiso eziqinile ze-FDA.

Ukubaluleka Kwesitifiketi Se-FDA

Ukuthola isitifiketi se-FDA kuyimpumelelo enkulu embonini yemishini yezokwelapha, futhi kukhombisa ukuzinikela kuka-Ningbo Baichen ekuhlangabezaneni nokudlula izindinganiso eziphakeme zokulawula e-United States.I-FDA idume ngenqubo yayo yokuhlola eqinile, eqinisekisa ukuthi imikhiqizo engena emakethe iphephile futhi isebenza ngempumelelo kubathengi.

Ukuzibophezela kuka-Ningbo Baichen Ekusebenzeleni Kahle

I-Ningbo Baichen Medical Devices Co. Ltd, okuyigama elihamba phambili embonini yemishini yezokwelapha, ihlale igcizelela kakhulu ikhwalithi, ukuphepha, kanye nokusungula izinto ezintsha.Lesi sitifiketi sakamuva siwubufakazi bokuzibophezela okungantengantengi kwenkampani ekuletheni imikhiqizo esezingeni eliphezulu kumakhasimende ayo.

Isiqephu 2

Mayelana ne-isihlalo sabakhubazekile sikagesi se-carbon fibre 

Isihlalo esinamasondo sika-Ningbo Baichen sikagesi siyisixazululo sokuguqula izinto esiklanyelwe ukuthuthukisa izimpilo zabantu abanezinselelo zokuhamba.Ngobuchwepheshe obuphambili kanye nedizayini ye-ergonomic, lesi sihlalo sabakhubazekile asihlinzeki nje kuphela ukuhamba okuthuthukisiwe kodwa futhi nokunethezeka nokusebenziseka kalula.

Indlela Eya Phambili

Njengoba isitifiketi se-FDA sisesandleni, i-Ningbo Baichen Medical Devices Co. Ltd isilungele ukwandisa ubukhona bayo emakethe yase-United States futhi inikeze okukhethekile kwayo.Isihlalo esinamasondo esinemotokubabukeli abaningi.Inkampani isazinikele ekuthuthukiseni ubuchwepheshe bokunakekelwa kwezempilo kanye nokwenza ngcono izinga lempilo yabantu abanezinkinga zokuhamba.

Isiphetho

Impumelelo ye-Ningbo Baichen Medical Devices Co. Ltd ekutholeni isitifiketi se-FDAIsihlalo Samasondo Sokunakekelwa Kwasekhayakuyingqophamlando ebalulekile egqamisa ukuzibophezela kwayo ekwenzeni okuhle.Njengoba beqhubekela phambili, ukuzinikela kwabo ekusunguleni nasekuqinisekiseni ikhwalithi kuthembisa impumelelo eqhubekayo embonini yemishini yezokwelapha.

 

isihlalo sabakhubazekile samandla

 

isihlalo sabakhubazekile sikagesi se-carbon fibre

 

Isihlalo esinamasondo esinemoto

 

Isihlalo Samasondo Sokunakekelwa Kwasekhaya

 

 

 


Isikhathi sokuthumela: Oct-10-2023