Burl Concepts, Inc.

Burl Concepts, Inc. manufactures the SONAS device, which is a non-invasive tool specifically designed to evaluate brain function in patients suffering from stroke or other neurological trauma. The device is intended to assist clinicians in making rapid, affordable assessments to improve patient outcomes in both hospital and non-hospital settings.

Burl Concepts, Inc. is based in the United States. The company’s location is relevant for understanding its regulatory and operational context, particularly when considering compliance with U.S. and international medical device regulations.

The SONAS device manufactured by Burl Concepts, Inc. is listed in the EU’s eudamed registry. This registry is used to track medical devices authorized for placement on the European market, ensuring transparency and traceability for regulatory oversight.

The SONAS device falls under Class I regulatory classification. This classification is typically assigned to devices that pose minimal risk to patients and users, such as general-purpose surgical instruments or non-invasive diagnostic tools like SONAS, which are intended for routine use without significant health risks.