VALUE PROVIDERS LLC

Value Providers LLC specializes in devices primarily focused on monitoring and analysis for diabetes and cardiovascular health. Their portfolio includes blood glucose and blood pressure monitoring systems designed for both home-use and point-of-care settings, such as rapid test analysers and monitoring systems. Additionally, they produce noninvasive blood pressure simulators, infrared thermometers (for ear and skin), and bioelectrical body composition analysers. These devices are developed to support self-management and clinical assessments.

Value Providers LLC is based in the United States. This location influences regulatory compliance, as their devices must adhere to FDA requirements. The company’s devices are classified under FDA’s Class I and Class II categories, which determine the level of regulatory oversight. Being U.S.-based also means their devices are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and transparency in the healthcare system.

Devices from Value Providers LLC are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system assigns a unique product identifier to each distinct device, enabling better tracking, safety monitoring, and regulatory compliance. This registry is critical for healthcare providers, insurers, and regulators to identify and manage devices accurately.

Value Providers LLC’s devices are classified under FDA’s Class I and Class II categories. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway and oversight required for each device type, ensuring appropriate scrutiny based on potential patient impact.