The udi medical device is explained as a medical device unique identifier, which is a string of codes consisting of symbols, numbers, or letters that are generally attached to medical device products and packaging.
It is the most important part of the medical device unique identification system, with global uniqueness, and can be used to accurately identify medical device products for regulatory and traceability purposes, so it is also known as the "digital ID" of medical device products.
UDI exists in the entire life cycle of medical device production, circulation and use, and is the basis for accurate identification of medical device information. Its implementation will reduce the barriers of under-recognized medical devices in the marketplace, quickly and accurately identify critical information about device safety and effectiveness, and reduce the number of medical errors that result.
UDI consists of two parts: product identification (DI) and production identification (PI):
DI is the static information of the product, which includes the enterprise code and the product ID. among them, the enterprise code is applied by the filer, and is issued by the code-issuing organization that conforms to the coding rules and standards for medical devices in China, and is a code with uniqueness.
PI is the product dynamic information, including production date, expiration date, production batch, serial number, calibration bit and so on.