Occuity Limited

Occuity Limited specialises in handheld optical devices designed for healthcare monitoring and screening. These devices are intended for both clinical and personal use, ensuring portability and accessibility. The PM1 is an example of their product line, which appears to focus on optical-based diagnostics or assessments.

Occuity Limited is based in the United Kingdom, which means its devices must comply with EU Medical Device Regulations (MDR) or In Vitro Diagnostic Regulation (IVDR) if applicable. Since the PM1 is classified as a Class IIa device, it requires conformity assessment procedures under EU regulations, including registration in the EU’s eudamed database to ensure traceability and market oversight.

Occuity Limited’s devices, such as the PM1, are listed in the EU’s eudamed database. This registry is critical because it provides transparency on device manufacturers, their products, and regulatory compliance within the European Economic Area. Listing in eudamed ensures traceability for healthcare providers, regulators, and patients, supporting safety and accountability in the medical device supply chain.

Occuity Limited’s devices, including the PM1, fall under EU Class IIa classification. This classification indicates a moderate risk level, requiring additional scrutiny such as clinical evaluations, technical documentation, and conformity assessment procedures. Class IIa devices must meet stricter safety and performance standards than lower-risk classes but do not require the same rigorous oversight as higher-risk categories like Class IIb or III.