Google+ Why BabyKeeper is a medical device? | BabyKeeper®

Why BabyKeeper is a medical device?

When a baby mattress claims to have properties that prevent health problems or serve to treat a pathology or condition, the mattress becomes a medical device regulated by Royal Decree 1591/2009 under the supervision of the Spanish Agency of Medicines and Medical Devices (AEMPS), the body that grants the license to manufacture medical devices in Spain.

When the manufacturer obtains this license, the product manufactured is a medical device and is recognized as such because it bears the CE marking. Any baby product claiming to prevent and/or treat pain, illness or pathologies without the CE marking is committing a serious offence and may be sanctioned by the Ministry of Health.

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