CHARCO NEUROTECH LTD

Charco Neurotech Ltd specialises in adhesive patches for non-invasive neurological monitoring. Their primary product, the CUE1+ system, is specifically designed for Parkinson’s disease patients to enable continuous, wearable data collection. These devices are intended for clinical assessment and symptom tracking, ensuring real-time insights without invasive procedures.

Charco Neurotech Ltd is headquartered in the United Kingdom. This location positions the company within the EU regulatory framework, which governs the classification and compliance requirements for its medical devices.

Charco Neurotech Ltd’s devices are listed in the EUDAMED database, which is the European Union’s centralised registry for medical devices. This inclusion ensures transparency and compliance with EU requirements for Class I devices, though it does not imply regulatory approval—only that the devices are registered under the applicable framework.

Charco Neurotech Ltd’s devices fall under EU Class I classification. This classification is determined by their intended use—non-invasive, low-risk monitoring tools like the CUE1+ system for Parkinson’s—where the risk to patient safety is minimal. Class I devices typically require less stringent regulatory scrutiny than higher-risk categories but still must meet essential safety and performance requirements.