Quality.
CE MEDICAL DEVICE CERTIFIED
Certified Medical Device
Our products are class I medical devices according to European regulations and are registered with the Spanish Agency for Medicines and Medical Devices (AEMPS).
Medical device manufacturing licence no. 6228-PS.
STANDARD 100 OEKO-TEX®
Free of harmful substances
All the materials that make up the Mimos Pillow, including the label and the sewing thread, are Oeko-Tex 100 class 1 certified for babies, the strictest in its classification.
ISO 13485
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.
SAFE SLEEPING ENVIRONMENT
CO2 re-inhalation safety
The Mimos Pillow has undergone independent laboratory tests and has been certified as safe against the risk of CO2 inhalation.
SAFE SLEEP
Anti-asphyxia safety
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 that a child can breathe if trapped in it. Tests show that the Mimos Pillow meets this safety standard.
BIOCOMPATIBLE
Non-irritant, non-cytotoxic and non-sensitizing
Tests at the Centro de Recerca en Toxicologia (CERETOX) of the Parc Científic in Barcelona certify that the Mimos Pillow is biocompatible.
HANDMADE IN BARCELONA – EUROPE
Handmade in Barcelona
Our products are manufactured from local materials and distributed worldwide from Barcelona.
