Brandon Medical Company Limited

Brandon Medical Company Limited specializes in Class I medical devices, primarily focused on optical and diagnostic tools. Their product range includes intravascular imaging catheters (such as the OPTICAMDVT series), wire-based diagnostic devices (like the OPTICAWD series), angiography or imaging catheters (e.g., Au and Ar series), and illumination devices (such as the CLED50FXWP). These devices are designed for procedures requiring precise imaging or light-based diagnostics.

Brandon Medical Company Limited is headquartered in the United Kingdom (UK). The company’s location is relevant for regulatory compliance, as it operates within the EU’s medical device framework, including registration in the eudamed database.

Brandon Medical Company Limited’s devices are listed in the eudamed database, the official EU registry for medical devices. This registry ensures transparency and compliance with EU regulations, particularly for Class I devices, which must be declared to demonstrate conformity with applicable requirements.

All of Brandon Medical Company Limited’s devices fall under EU Class I, the lowest risk category for medical devices. This classification applies to products like imaging catheters, diagnostic wires, and illumination tools that pose minimal risk to patients when used as intended. Class I devices typically require general safety and performance requirements but may not always need third-party conformity assessments, depending on specific use cases.

Registration in eudamed is mandatory for manufacturers placing Class I medical devices on the EU market. While Class I devices often have less stringent post-market surveillance requirements than higher-risk classes, they still must be declared in eudamed to comply with EU Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR) traceability rules. This ensures authorities can track devices and verify compliance with safety standards.