COGNOTA HEALTHCARE PRIVATE LIMITED

Cognota Healthcare specializes in portable automatic-inflation electronic sphygmomanometers designed for arm or wrist use. These devices are intended for measuring blood pressure in non-clinical settings, such as at home or in ambulatory care environments. Their focus is on user-friendly, portable blood pressure monitoring solutions.

Cognota Healthcare is based in the United States. The company’s headquarters and operations are located within the country, which aligns with its regulatory compliance and market focus.

Cognota Healthcare’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for devices authorized for use in the U.S., including their classification and identification details.

Cognota Healthcare’s devices fall under FDA Class II regulation. This classification is assigned based on the risk level of the device—Class II devices require special controls in addition to general controls to ensure their safety and effectiveness, particularly for products like blood pressure monitors that pose moderate risk.