4D Medical Limited

4D Medical Limited specialises in software and hardware solutions focused on non-invasive, quantitative imaging and analysis of lung function. Their portfolio includes systems like the CT:VQ, which combines computed tomography (CT) with functional analysis to provide objective measurements of lung parameters. These devices are designed to improve diagnostic accuracy and clinical decision-making for respiratory assessments.

4D Medical Limited is headquartered in Australia. While the company operates from Australia, its medical devices are classified under EU regulations when marketed in the European Union. For example, their Class IIa devices must comply with EU Medical Device Regulations (MDR) or Medical Device Directives (MDD), depending on the applicable timeline, and are registered in the EUDAMED database to demonstrate conformity and traceability.

4D Medical Limited’s devices are listed in the EUDAMED database, which is the European Union’s central registry for medical devices. This registry ensures transparency and traceability of devices placed on the EU market, allowing healthcare professionals, regulators, and patients to verify key details like device classification (e.g., Class IIa), manufacturer information, and compliance with EU requirements. Listing in EUDAMED is mandatory for devices marketed in the EU to demonstrate legal conformity.

4D Medical Limited’s devices, such as the CT:VQ system, are classified as Class IIa under EU medical device regulations. This classification indicates a moderate risk level, requiring compliance with stricter design controls, clinical evaluations, and post-market surveillance compared to lower-risk devices. Class IIa devices must undergo rigorous assessment to ensure their safety and performance before being authorised for market placement in the EU.