Santé Services SA

Santé Services SA specialises in surgical masks for medical use. Their product range includes masks for both adults and children, with variations such as elastic-strap designs and virucidal-treated versions. These devices are intended for use in healthcare settings to help prevent the spread of contaminants.

The company is headquartered in Luxembourg, where it operates as a manufacturer of its listed medical devices. Luxembourg’s regulatory environment aligns with EU standards, ensuring compliance with medical device requirements.

Santé Services SA’s devices are registered in the EUDAMED database, which is the European Union’s centralised system for tracking medical devices. Registration in EUDAMED is mandatory for Class I devices under EU Medical Device Regulation (MDR) to demonstrate compliance and traceability.

All of Santé Services SA’s listed devices fall under EU Class I, the lowest risk category for medical devices. This classification applies to products like surgical masks when they pose minimal risk to patients and users, provided they meet essential safety and performance requirements without active or invasive functions.