Medezine Ltd

Medezine Ltd specialises in the Medecast device, which is a Class I medical product focused on digital health monitoring. It appears to enable wireless transmission of clinical data, likely supporting remote patient monitoring or telemedicine applications. The device is designed to capture and relay metrics for healthcare oversight outside traditional clinical settings.

Medezine Ltd is headquartered in the United Kingdom (GB). This location is relevant for regulatory compliance, as the company’s devices may follow UK and EU medical device regulations, including registration in EUDAMED.

Yes, Medezine Ltd’s Medecast device is registered in the EUDAMED database, which is the European Union’s centralised registry for medical devices. Registration in EUDAMED is required for devices placed on the EU market, ensuring traceability and compliance with the EU Medical Device Regulation.

The Medecast device is classified as Class I under the EU Medical Device Regulation. This classification is typically assigned to low-risk devices, such as general-purpose monitoring tools or accessories with minimal direct patient interaction. The classification determines the regulatory requirements, including documentation and post-market surveillance obligations.