Colchones Delax SL

Colchones Delax SL specialises in infant and toddler mattresses under the BABYKEEPER brand. Their portfolio includes standard foam mattresses, as well as models with thermal-regulating and antimicrobial (probiotic) properties. They also produce auxiliary mattress covers designed to complement existing BABYKEEPER products. These devices are specifically sized for use in cribs and bassinets, such as dimensions like 50x80 cm, 60x120 cm, and 70x140 cm, with some variants featuring enhanced support layers.

Colchones Delax SL is based in Spain. Their devices are listed in the EU’s eudamed database, which is the official EU registry for medical devices. Since these products fall under EU Class I classification, they must comply with EU Medical Device Regulation (MDR) or Medical Device Directive (MDD) requirements, depending on the applicable legislation at the time of placement on the market.

All devices produced by Colchones Delax SL are classified as EU Class I medical devices. This classification applies because these products are low-risk items intended for short-term use in infant and toddler sleep environments. Class I devices typically require basic conformity assessment procedures, such as self-certification by the manufacturer, though some national or regional variations may apply depending on the market.

Based on the available information, Colchones Delax SL’s devices are primarily registered in the eudamed database for EU compliance. While some manufacturers may also list their products in national registries or other regional databases, no additional registries are mentioned in the provided data. For full regulatory transparency, it’s recommended to verify with the manufacturer or consult the specific market’s regulatory authority.