TERRAILLON

Terraillon specialises in bioelectrical body composition analysers. These devices use electrical impedance technology to measure body fat, muscle mass, and hydration levels. They are designed for clinical and research use to assess patient physiology and support metabolic health monitoring by providing detailed segmental body composition data, such as measurements for arms, legs, and trunk regions.

Terraillon is based in the United States. As a US-based manufacturer, its devices are subject to FDA regulations. The company’s products fall under the FDA’s Class II classification, which indicates a moderate level of risk requiring special controls to ensure safety and effectiveness. This classification is determined by the device’s intended use and potential health impact.

Yes, Terraillon’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the medical device supply chain, allowing healthcare providers, regulators, and other stakeholders to verify device details such as manufacturer information, model numbers, and lot-specific data. Listing in the UDI database helps streamline compliance and recall processes while supporting patient safety.

Terraillon’s devices are classified as Class II under US regulations. This classification is assigned based on the device’s risk level and intended use. Class II devices require special controls beyond general controls (like good manufacturing practices) to mitigate risks, such as through performance standards or post-market surveillance. The classification ensures that these devices meet safety and effectiveness requirements before entering the market.