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NĀ MAKAhiki O KA ʻIKE
ʻO BILENS kahi mea hoʻolako i nā ʻenehana lapaʻau nani a me nā hoʻonā e pili ana i ka ikehu no ke ʻoki kino, nā ʻano lapaʻau aesthetics a me nā mākeke nani.
Hana pololei nā lako hana ʻo BILENS e like me ISO13485 a ua kūlike kā mākou huahana āpau me nā palapala hōʻoia ʻEulopa Lapaʻau CE ma lalo o nā Rula (EU) 2017/745(MDR). Ua loaʻa i kā mākou huahana kiʻekiʻe nā palapala hōʻoia o US FDA 510K, Australia TGA, Brazil Anvisa.
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ISO 13485Nā mea lapaʻau -
Ka palena oNā Mea Pōʻino -
Nā mea hoʻonaniKa māka ʻana o CE -
ʻO ka FDA o ʻAmelika Hui Pū ʻIaUa hoʻomaʻemaʻe ʻia ʻo 510K -
Nā mea lapaʻauKa māka ʻana o CE2017/745/EU (MDR) -
Kino i hoʻomaopopo ʻia
NĀ PONO
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