Our mattresses in the range Care® has a health certificate with license number 8849-PS issued by the Spanish Agency for Medicines and Health Products (AEMPS), which belongs to the Ministry of Health. But what does it mean for a crib mattress to be a health product?
Definition of medical device
According to the Ministry of Health, a medical device is defined as any instrument, device, equipment, computer program, implant, reagent, material, or other article intended by the manufacturer to be used on humans, separately or in combination, for any of the following specific medical purposes:
- Diagnosis, prevention, monitoring, prediction, prognosis, treatment, or relief of a disease.
- Diagnosis, monitoring, treatment, relief, or compensation for an injury or disability.
- Research, replacement, or modification of anatomy or a physiological or pathological process or condition.
- Obtaining information through the in vitro examination of samples from the human body, including organ, blood, and tissue donations.
Medical devices do not exert their main action inside or on the surface of the human body through pharmacological, immunological, or metabolic mechanisms, but their function may contribute to such mechanisms. It could be said that a medical device is one that is used in the field of health without being a medicine.
Care® mattresses with health certification
The ECUS Kids catalog features mattresses from the range as medical devices. Care®.
Crib, mini-crib, and bassinet mattresses Care® They are certified for the prevention of plagiocephaly and sudden infant death syndrome (SIDS). Its foam topper in the form of small bubbles reduces the pressure exerted on the baby's head by up to 70%. This foam design also creates air channels inside the mattress, making it more breathable and helping to prevent the risk of suffocation.
Crib and mini-crib mattresses Care® Ultimate, in addition to the above, adds less pressure on the baby's body and regulates temperature thanks to the use of more breathable foam and a special fabric cover.
Children's mattresses Care® Junior is also classified as a medical device by the AEMPS (Spanish Agency for Medicines and Health Products). In this case, because it is a mattress designed to prevent deformities. musculoskeletal in children between the ages of 2 and 12, promote correct posture during sleep and ensure adequate rest adapted to children's growth.
The Care® Up anti-reflux wedge helps raise the baby's torso at the angle recommended by pediatricians to prevent gastroesophageal reflux and respiratory conditions. By ensuring that the baby sleeps in an upright position, the accumulation of mucus in the upper respiratory tract is reduced, preventing coughing and improving breathing. Both reflux and bronchiolitis are two very common conditions in babies that the Care® Up wedge helps to alleviate so that your baby can rest healthily and safely.
