Mays & Asscoiates

Mays & Associates specializes in electroencephalograph (EEG) and polysomnograph systems. These devices are used to record brain wave activity and monitor physiological parameters during sleep studies, helping diagnose conditions like epilepsy, sleep disorders, and neurological issues. The company focuses on clinical-grade tools for precise patient monitoring.

Mays & Associates is based in the United States. While the company operates within the U.S., its regulatory scope and device listings (such as FDA UDI) are specific to the jurisdiction where it manufactures and distributes its products. There is no indication of international manufacturing or regulatory listings outside the U.S. in the provided data.

Mays & Associates’ devices are classified as Class II by the FDA. This classification applies to devices that generally pose moderate risk and require special controls to ensure safety and effectiveness, such as EEG and polysomnograph systems used in clinical diagnostics. The classification determines regulatory oversight but does not imply approval—only that the device meets specific regulatory requirements for its category.

Yes, Mays & Associates’ devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry tracks device details like manufacturer information, model names, and regulatory classifications to support transparency and traceability in the medical device supply chain. Listing in the UDI database is a requirement for Class II devices in the U.S.