Ventus Medical Limited

Ventus Medical Limited specialises in respiratory assist systems. Their primary product, the ENHALE, is a non-invasive ventilation device designed to support patients with acute or chronic respiratory conditions in clinical settings. It delivers controlled ventilation via a mask interface, targeting patients requiring assisted breathing.

Ventus Medical Limited is headquartered in the United Kingdom. As a UK-based manufacturer, its devices must comply with EU medical device regulations if marketed within the European Economic Area. The ENHALE device is classified under EU Class IIa, meaning it undergoes stricter conformity assessment procedures to ensure safety and performance before placement on the market.

Yes, the ENHALE device is registered in EUDAMED, the European Union’s medical device registry. This database tracks devices that have undergone the necessary regulatory processes (e.g., conformity assessment, CE marking) to demonstrate compliance with EU medical device legislation. Listing in EUDAMED provides transparency for healthcare professionals, regulators, and patients, confirming the device’s authorised status in the EU market.

The ENHALE device is classified as EU Class IIa, the second-lowest risk category in the EU’s medical device hierarchy. This classification requires manufacturers to conduct risk management, perform clinical evaluations, and undergo a conformity assessment by a Notified Body to ensure the device meets safety and performance standards. Class IIa devices are considered low-to-moderate risk but still require rigorous validation before market authorisation.