In Europe.
The CE marking establishes the conformity of a product to European legislation, allowing it to freely circulate within the European Economic Area. Several classes of medical devices exist, from class I (low risk) to class III (high risk).
OdySight is a class I medical device which is CE marked (self-certification) according to the rules related to the medical devices of the Directive 93/42/EC.
Our Quality Management System is in compliance with the standard ISO 13485 :2016.
In USA.
OdySight is a medical device class I, 510k exempted (FDA Enforcement Policy for Remote Ophthalmic Assessment and Monitoring Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency)