Euphoria Premium Color Lenses

All our products have passed 14 different sterilization tests and have certificates from independent EU organizations, as well as important safety markings such as CE, KFDA, GMP, ISO9001, and ISO13485. They are sold safely in a total of 38 countries, primarily in the USA, Canada, Russia, European countries, and Arab countries.

Reference standards

5 YEARS FROM DATE OF STERILIZATION STORE 20-25C

3.1 EN ISO 17665-1:2006. Sterilization of health care products – Moist heat

3.2 EN 556-1:2001, Sterilization of medical devices

3.3 EN ISO 11138-3:2006, Sterilization of health care products – Biological indicators

3.4 EN ISO 11737-1:2006 Sterilization of medical devices – Microbiological methods –

3.5 EN ISO 11607-1:2009, Packaging for terminally sterilized medical devices-

3.6 EN ISO 11607-2:2006, Packaging for terminally sterilized medical devices

3.7 EN ISO 13485:2012. Medical devices-Quality management system- 3.8 MDQMT-AG-2007-02, Guideline for Sterilization validation of medical devices

3.8 MDQMT-AG-2007-02, Guideline for Sterilization validation of medical devices

3.9 Korea Pharmacopoeia 8 th, General test method – Sterility test

3.10 EN ISO 10993-1:2009,EN ISO 10993-5 EN ISO 10993-3-12:2012 EN62366:2008

3.11-MIT international testing S.r.I.(NB0068) GMDN CODE:10996 (YO-TF-01-07)

3.12-Sertificate of GMP medical devices manifacturing Practices } \underline{17.03 .2021}}$

3.13 -Full quality assurance system approval EC certificate 22.07.2023 (CE0068)

3.14-Notify body number:0068/QCO-DM/042-2018 via Moscova.11-20017RHO-ITALY

CERTIFICATE OF ANALYSIS

POWER,BASE CUREVE,CENTER THICKNESS, DIAMETER,SURFACE INSPECTION ACCEPT (PASSED)