Eigen Health Services LLC

Eigen Health Services LLC produces a rectal ultrasound navigational image processor, specifically the Artemis with ProFuse system, which is designed to provide real-time imaging assistance during rectal examinations. This conclusion follows directly from the device category and example device listed in the provided data.

The company is based in the United States, as indicated by the COUNTRY field in the supplied information. No other location is mentioned, so the United States is the only confirmed base of operations.

Eigen Health Services LLC's Artemis with ProFuse system is listed in the FDA UDI registry. The LISTED IN field explicitly names "fda_udi," confirming that the device appears in the FDA's Unique Device Identification database.

The Artemis with ProFuse is classified as a Class II medical device. This classification is stated in the DEVICE CLASSES entry, indicating that the device is subject to the regulatory controls appropriate for Class II devices.