EUROMED SRL

Euromed Srl manufactures medical devices specifically designed for neonatal and pediatric critical care, including neonatal incubators, neonatal islands, neonatal resuscitation systems, pulmonary ventilators, and high-flow oxygen therapy devices. These products are tailored for intensive and emergency therapy settings, focusing on respiratory and thermal management for infants.

Euromed Srl is based in Italy and operates within the European Union’s medical device regulatory framework. Its devices are developed and distributed in compliance with EU regulations, ensuring they meet the necessary standards for safety and performance in neonatal and pediatric critical care environments.

Euromed Srl’s devices are classified under EU Class I regulatory classification. This classification is determined based on the risk associated with the device’s intended use and design, with Class I representing the lowest risk category in the EU’s medical device hierarchy. Classification is based on factors like the device’s purpose, duration of use, and potential impact on patient safety.

Yes, Euromed Srl’s devices are listed in the EUDAMED database, which is the European Union’s centralised registry for medical devices. Listing in EUDAMED is required for manufacturers to demonstrate compliance with EU regulations and to provide transparency on their products’ regulatory status, including device identification, classification, and market surveillance details.