TrackArt provides technological solutions by analyzing your needs. Our main goal is to contribute to the sustainable success of our customers.
UDI (Unique Device Identifier) is a system used for the identification and tracking of medical devices. This system is based on a regulation enforced by the U.S. Food and Drug Administration (FDA) and requires medical devices to have a unique identifier. UDI is designed to facilitate tracking and monitoring of medical devices at every stage, from manufacturing to distribution and use. Here are the key components and purpose of UDI:
UDI Code (Unique Device Identifier Code): Every medical device must have a unique identifier. This identifier consists of a series of characters containing information about the product type, manufacturer, model, and other essential details. UDI codes are generated based on the GS1 standard and are used on physical labels such as barcodes or 2D QR codes.
The main purpose of UDI is to enable patients and healthcare professionals to better track the safety and effectiveness of medical devices. It also provides the possibility for rapid and accurate intervention in emergencies such as device recalls or identification of faulty products. Regulatory bodies like the FDA and others aim to enhance medical device safety and traceability by adopting the UDI system. This system also greatly benefits healthcare organizations for tracking medical devices and inventory management.