Our Certifications

iso-9001-2015-2023

ISO 9001:2015

iso-13485-2016-2023

EN ISO 13485:2016

4

EC Certificate

5a

MDSAP Certificate

8

MDA Establishment License

9a

MDA Product Registration (Aspheric)

10-mda-product-registration-toric

MDA Product Registration (Toric)

11a

MDA Product Registration (Aveo Hello)

12a

MDA Product Registration (Aveo Joy)

13a

USA FDA 510K

14a

USA FDA 510K

15

Brazil ANVISA Product Registration (Aspheric)

16a

Health Canada Medical Device Licence

17

Japan MHLW Registration Certificate

18

Japan PMDA Product Registration (Daily Aspheric)

19a

Singapore HSA Product Registration (Daily)

20a

Singapore HSA Product Registration (Biweekly & Monthly)

21

Korea GMP Certificate

22a

Korea KFDA Product Registration (Daily Aspheric)

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