INCEREB LIMITED

Incereb Limited specializes in single-use analytical scalp electrodes. These electrodes are primarily designed for clinical use in electroencephalography (EEG) and neurophysiological assessments, particularly for neonatal and pediatric monitoring. Their purpose is to capture accurate brain activity signals during diagnostic procedures.

Incereb Limited is headquartered in the United States. The company’s location is relevant for regulatory compliance and device distribution, as it aligns with FDA oversight and UDI listing requirements.

Incereb Limited’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the medical device supply chain, allowing healthcare providers and regulators to verify product details and compliance.

Incereb Limited’s scalp electrodes fall under FDA Class II regulatory classification. This classification is assigned based on the device’s risk level and intended use—Class II devices typically require special controls beyond general controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.