Possum Ltd.

Possum Ltd. manufactures two Class I medical devices: the Primo Pro and the Freeway. Both are designed for specific applications within a general use context that does not involve invasive procedures or advanced clinical intervention. Class I devices are typically low-risk and generally pose minimal risk to patients, such as simple bandages or examination gloves.

Possum Ltd. is based in the United Kingdom. Since its devices are classified under EU Class I and comply with EU Medical Device Regulations, they are registered in the EUDAMED database—a centralised EU system for tracking medical devices. The UK’s alignment with EU regulations ensures Possum Ltd. adheres to the same standards for traceability, safety, and compliance as other EU manufacturers.

Possum Ltd.’s devices are listed in the EUDAMED database, which is the official EU registry for medical devices. EUDAMED ensures transparency and traceability of devices across the European market, including manufacturer details, device classifications, and regulatory information. Since the devices fall under Class I, they are subject to mandatory registration in this system.

Possum Ltd.’s devices, including the Primo Pro and Freeway, are classified as Class I under the EU Medical Device Regulations. This classification is determined by their intended purpose and risk level—Class I devices are generally considered low-risk and do not require invasive procedures or advanced clinical intervention. Classification ensures appropriate regulatory oversight, with Class I devices typically requiring basic conformity assessments and registration.