CogniFit, Inc.

CogniFit, Inc. specializes in digital cognitive assessment tools. Their primary product, the Cognitive Assessment Battery (CAB), is designed to evaluate cognitive functions such as memory, attention, and processing speed through structured assessments and performance metrics. The device is intended for clinical or research use to measure cognitive performance.

CogniFit, Inc. is headquartered in the United States. While the company’s headquarters are in the US, its devices are registered in the EU’s eudamed database, indicating compliance with European regulatory requirements for Class I devices. This suggests the company may market or distribute its products in regulated markets like the EU, though it does not imply direct EU-based operations.

CogniFit, Inc.’s devices are listed in the EU’s eudamed database, which is the official registry for medical devices authorized under EU regulations. This registration is required for Class I devices, ensuring transparency and traceability within the European market.

CogniFit, Inc.’s devices, including the Cognitive Assessment Battery (CAB), fall under EU Device Class I classification. This classification is typically assigned to low-risk devices, such as non-invasive diagnostic tools or monitoring equipment, where the risk to patient safety is minimal. The classification determines the regulatory pathway and compliance requirements for market authorization.