Certifications Desio Colored Contact Lenses

UNI EN ISO 9001:2015

It is the internationally recognized standard for business quality management and applies to the processes that create and control an organization’s products and services.
It prescribes systematic control of activities to ensure that customer needs and expectations are met.

Certifications Desio Colored Contact Lenses

UNI EN ISO 13485:2016

It specifies the requirements for a quality management system where an organization must demonstrate its ability to provide medical devices and related services that meet customer needs and applicable regulatory requirements for medical devices and related services. The primary goal of EN ISO 13485:2016 is to facilitate the medical device’s compliance with regulatory requirements for quality management systems.

Certifications Desio Colored Contact Lenses

CE Mark

A mandatory conformity mark for products placed on the market in the European Economic Area (EEA). With the CE marking on a product, the manufacturer ensures that the product complies with the essential requirements of the applicable CE directives.

Certifications Desio Colored Contact Lenses

FDA 510k

The Food and Drug Administration (FDA or USFDA) is the agency of the United States Department of Health and Human Services. It is the FDA’s responsibility to protect and promote public health. An FDA certificate ensures that a product meets the US FDA requirements for medical devices sold in the United States.

  • SDFA Saudi Arabia – Food and Drug Authority
  • CAPA Approval
  • Egypt Medical Advice Registration
  • Medical Device Registration in the UAE
  • AMAR- Medical Device Registration and Approval in Isreae
  • DMP Approval – Marocco Medial device registration
  • ANMAT  – The National Administration of Drugs, Foods and Medical Devices in Argentina

Certificate of Free Sale issued by the Italian Ministry of Health.

Local certifications have been obtained in the respective foreign countries.