What is UDI code
Unique Device Identification， UDI, abbreviated as UDI, is a globally recognized coding system designed to provide a unique numerical identifier for each medical device. UDI code can not only identify the model, production date, producer and other information of medical devices, but also be queried and traced through an internationally unified database, thereby improving the safety of medical devices, reducing the safety hazards caused by repeated use, and providing a technical foundation for the interconnection of global medical systems
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The composition structure of UDI code
The UDI code consists of two parts: Device Identifier (DI) and Production Identifier (PI)
Product Identification (DI): A unique code specific to a particular specification, model, and packaging of medical devices. Used to identify information such as specifications, models, batches, or serial numbers of medical devices. DI can serve as the "access keyword" for storing information in the database that uniquely identifies medical devices. It is composed of numbers, including packaging code, manufacturer identification code, product item code, and checksum
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Production Identification (PI): Information related to the production process of medical devices, including production date, expiration date, production batch, serial number, etc. PI can be formulated according to actual application needs and used together with DI
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Application scenarios of UDI code
UDI codes play an important role in the production, circulation, use, and recall of medical devices
Production process: The manufacturer assigns a unique UDI code to each product and associates it with the production information of the product for subsequent traceability and management
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Circulation process: UDI code helps medical institutions, distributors, and regulatory authorities quickly identify the source, specifications, expiration date, and other information of products, ensuring the legality and safety of products
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In medical institutions, UDI coding helps to quickly identify and use the correct medical devices
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The Current Status and Trends of Global UDI Code Applications
There are multiple independent identification management frameworks in the global healthcare system, leading to some confusion in the circulation of medical devices worldwide. This decentralized management approach not only increases regulatory costs, but may also lead to incompatible use of medical devices between different countries and regions. Therefore, a unified unique identification system for medical devices is particularly important. The introduction and application of UDI encoding can achieve unified management of medical devices worldwide, improving the efficiency and safety of the medical system
Technical advantages and application scenarios of UDI code inkjet printer
Compliance tool: The UDI code inkjet printer uses laser etching, heat transfer or inkjet technology to accurately mark the UDI code on the surface of the instrument in the form of a barcode, dynamic QR code or RFID electronic tag, ensuring clear, durable and tamper proof identification. For example, a certain heart stent company used UDI code printers combined with encrypted QR codes to achieve full chain information locking from raw material procurement to factory logistics, increasing compliance efficiency by 50%
1.Quality Revolution: UDI code inkjet printer promotes the transformation of medical device quality management from passive response to active prevention. By seamlessly integrating with the Manufacturing Execution System (MES), process parameters are recorded in real-time to generate a "digital twin" file of the equipment. For example, a certain orthopedic implant company has achieved an accuracy rate of up to 90% in predicting production defects by using UDI code printers and scanning guns in conjunction, eliminating quality hazards in the early stages
2.Supply chain optimization: UDI code inkjet printer helps enterprises track the flow of products in the supply chain, timely understand inventory and sales situation, optimize logistics and inventory management, improve operational efficiency and cost control ability
3.Application cases in different industries
Medical device industry: UDI code inkjet printers deeply integrate high-precision identification with one object one code technology, endowing each medical device with a unique "digital ID card" to meet regulatory requirements and promote quality management throughout the entire lifecycle
4.Cosmetics industry: UV inkjet printers print UDI codes on cosmetics to improve product traceability, enhance brand image and reputation, combat counterfeit and inferior products, and improve supply chain management efficiency
5.Food industry: UV inkjet printers apply UDI codes in the food industry to achieve full traceability and enhance food safety and consumer trust. Its high resolution and high temperature resistance make it possible to achieve clear printing even on complex packaging