CE marking and regulations 

At CASPE and UNIMEDIS MEDICAL, we make it a priority to ensure that 100% of the products available on our website comply with current regulations.

Materiovigilance therefore involves reporting these incidents, assessing the risk, informing the ANSM, informing users, implementing corrective actions, and, if necessary, recalling the products concerned.

Materiovigilance is concerned with the monitoring of incidents or risks of incidents that may result from the use of medical devices placed on the market. (Art. R5212.1 of the Public Health Code).

Thanks to our UNITRACK traceability system, we are able to locate each product sent (batch number, shipping date, contact details of the customer delivered) and thus be able to contact the customers concerned by a possible product recall or safety information.

As a healthcare professional or user of medical devices, you are directly concerned by the safety of use and reporting in case of non-compliance.

The National Agency for the Safety of Medicines and Health Products (ANSM) is the public body in France responsible for the safety of medicines and other health products throughout their life cycle.