Our Certifications

mda-iso

MDA ISO13485:2012

BS EN ISO 13485:2016

BS EN ISO 13485:2016

BS EN ISO 9001:2015

BS EN ISO 9001:2015

FDA 510(K)

FDA 510(K)

KOREA Certificate of GMP

KOREA Certificate of GMP

Japan MHLW-Registration Certificate

Japan MHLW-Registration Certificate

MDA Product Registration

MDA Product Registration

MDA ESTABLISHMENT LICENCE

MDA ESTABLISHMENT LICENCE

ISO 13485 Q2N 17 02 97247 001

ISO 13485 Q2N 17 02 97247 001

G2 097247 0002 Rev. 01

G2 097247 0002 Rev. 01

TUV Cert ISO 13485:2016

TUV Cert ISO 13485:2016

TUV Cert ISO 9001:2015

TUV Cert ISO 9001:2015

Health Canada Medical Device Licence NO.: 99716

Health Canada Medical Device Licence NO.: 99716

Brazil Anvisa Aspheric Lens Approval

Brazil Anvisa Aspheric Lens Approval

Japan PMDA Daily Aspheric Lens Approval

Japan PMDA Daily Aspheric Lens Approval

Korea KFDA Daily Aspheric Lens Approval

Korea KFDA Daily Aspheric Lens Approval

Singapore HSA Daily Aspheric Lens Approval

Singapore HSA Daily Aspheric Lens Approval

Singapore HSA Biweekly & Monthly Aspheric Lens Approval

Singapore HSA Biweekly & Monthly Aspheric Lens Approval

Korea KFDA Daily Aspheric Lens Approval

Korea KFDA Daily Aspheric Lens Approval

Singapore HSA Daily Aspheric Lens Approval

Singapore HSA Daily Aspheric Lens Approval

Singapore HSA Biweekly & Monthly Aspheric Lens Approval

Singapore HSA Biweekly & Monthly Aspheric Lens Approval

USA FDA 510K

USA FDA 510K

Korea - Certificate of Free Sales ( 2 Weeks & 1 month )

Korea - Certificate of Free Sales ( 2 Weeks & 1 month )

MDA Product Registration (Aveo Hello)

MDA Product Registration (Aveo Hello)

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