010203040506
16
IMINYAKA YAMAVA
I-BILENS ngumboneleli wezobuchwepheshe bezonyango zobuhle kunye nezisombululo ezisekelwe kumandla kwiimarike zotyando, ubuhle bezonyango kunye nobuhle.
Izixhobo zokwenza iBILENS zihambelana ngqo ne-ISO13485 kwaye zonke iimveliso zethu ziyahambelana nezatifikethi ze-European Medical CE phantsi kweMigqaliselo (EU)2017/745(MDR). Iimveliso zethu ezikumgangatho ophezulu zifumene izatifikethi ze-US FDA 510K, Australia TGA, Brazil Anvisa.
-
I-ISO 13485Izixhobo zonyango -
Umda weIzinto Eziyingozi -
Izixhobo zobuhleUkumakishwa kwe-CE -
I-FDA yaseMelikaI-510K isusiwe -
Izixhobo zonyangoUkumakishwa kwe-CE2017/745/EU (MDR) -
Umzimba oxeliweyo
IINZUZO
010203040506
01






