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Medical Device UDI Code Reading Solution

2022-10-03 16:16:00 Alexandra Miller

With the promulgation of the "Medical Device Unique Identification System Rules" issued by the State Drug Administration, it marks that the medical device industry has officially entered the era of traceability and control of one item, one code.


The UDI medical device unique identification is to improve the ability of manufacturers and regulatory authorities to trace and control all links in the supply chain, and to promote the immediate and efficient recall of devices with safety risks. For domestic medical device manufacturers, they should take the lead in implementing UDI by understanding UDI Only by mastering UDI coding technology can we gradually integrate with international standards and share a unique medical device identification code system.


1. The Overall Process of UDI Implementation

UDI has unique coding rules, endowing each product with a unique identity, ensuring that the source of each product can be traced, and its whereabouts can be traced, while regulating and controlling all production processes of the product.

UDI實施流程圖

2. UDI Code Composition

UDI編碼構(gòu)成圖示

  • DI code: a globally unique code given to the company by the code-issuing agency based on the company and product information, including company information, specifications, models, packaging and other information.

  • PI code: the unique internal code given to the product by the enterprise itself.

  • UDI code: realize the global unique identification code of each product.

UDI碼印制使用示意圖

UDI碼生產(chǎn)流程管控示意圖

3. HEROJE Code Reading Solution

Thanks to HEROJE's UDI code reading hardware support, it can meet the production coding application scenarios of various packaging and different production lines. It is suitable for packaging materials such as cartons, cartons, metals, plastics, and films, and helps companies customize UDI compliance. implementation plan. The solution or reading UDI code includes handheld code readers and fixed-mount code readers.

合杰UDI碼手持式掃碼器  合杰UDI碼固定式讀碼器