Quality and safety are essential elements in our company from day one. That is why we have carried out several studies to prove it. In addition, our ISO 13485 quality system enables us to maintain product integrity and quality throughout the manufacturing and distribution chain.
Certified Medical Device
Our products are class I medical devices according to European regulations and are registered with the Spanish Agency of Medicines and Medical Devices (AEMPS).
Medical device manufacturing license no. 6228-PS.
STANDARD 100 OEKO-TEX®
Free of harmful substances
All materials that make up the Mimos Pillow, including the label and sewing thread, are Oeko-Tex 100 class 1 certified for babies, the strictest in its classification.
Quality Management System
Our quality management system complies with the international standard ISO 13485, especially for medical device manufacturers. This system ensures that the medical devices manufactured are safe, suitable for their intended use and comply with legal requirements.
A SAFE REST
CO2 re-inhalation safety
The Mimos Pillow has undergone independent laboratory studies and has been certified as safe against the risk of CO2 inhalation.
A SAFE REST
The certification body TÜV Rheinland has developed a standard and corresponding tests to assess the suffocation risk of children’s mattresses and pillows. This standard specifies the minimum amount of airflow that must pass through a textile material to ensure the child’s breathing if trapped in it. Tests show that the Mimos Pillow meets this safety standard.
Non-irritant, non-cytotoxic and non-sensitizing
Studies at the Toxicology Research Center (CERETOX) of the Barcelona Science Park certify that the Mimos Pillow is biocompatible .