ENDRA Life Sciences, Inc.

Endra Life Sciences, Inc. manufactures the TAEUS FLIP SYSTEM, a non-invasive medical device designed to measure liver fat content. This technology is intended for clinical use as an alternative to MRI-based assessments, helping to evaluate liver health without the need for invasive procedures.

Endra Life Sciences, Inc. is based in the United States. While the company itself is not subject to EU regulatory approvals, its TAEUS FLIP SYSTEM is listed in the eudamed registry, indicating it has undergone the necessary EU regulatory processes (such as CE marking) to be legally marketed in Europe. This reflects compliance with EU medical device regulations, even though the company’s headquarters are outside the EU.

The TAEUS FLIP SYSTEM is classified as a Class IIa medical device. This classification is determined by its intended use—non-invasive measurement of liver fat—and its associated risk level. Class IIa devices require compliance with specific EU regulations, including clinical evaluations and conformity assessments, but they are considered lower-risk than higher-class devices like Class IIb or III.

The TAEUS FLIP SYSTEM is listed in the eudamed registry, which is the official EU database for medical devices. Listing in eudamed confirms that the device has met EU regulatory requirements (such as CE marking) and is legally authorized for sale within the European Economic Area. This transparency helps healthcare professionals, regulators, and patients verify the device’s compliance status.

The TAEUS FLIP SYSTEM is designed as a non-invasive alternative to MRI-based liver fat assessment. Unlike MRI, which is costly and requires specialized equipment, the TAEUS system uses proprietary technology to measure liver fat content in a more accessible and affordable way—without exposing patients to radiation or contrast agents. This makes it a practical option for broader clinical use in evaluating liver health.