What does UDI mean?

UDI (Unique Device Identification) is a worldwide system for uniform product labeling of medical devices, that was developed in the USA, UDI is intended to sustainably improve the safety and quality of medical devices. UDI consists of three components:


UDI includes a Device Identifier (DI) and a Production Identifier (PI). The DI is a fixed, ISO-based code for identifying the article and the manufacturer. Variable data such as serial and batch numbers or the expiration date are stored in the PI.


The UDI data carriers are primarily labels. The UDI marking must be machine-readable - for example as 1D or 2D barcode in the GS1 or HIBC standard - and in plain text on the product and / or packaging.


Certain product information must be recorded centrally in the Global Unique Device Identification Database (GUDID). Products can be researched unambiguously in the database via the UDI. The database is publicly available and can be used by patients and doctors.

Example UDI label v3

 

Your advantages: UDI with KUMAVISION

   Increased patient safety
   Legally binding marking
   Accelerated workflows
   Everything in an ERP software
   Improved label quality

  Complete traceability
   Simplified logistics processes
   Standardized, worldwide procedure
   Optimized approval processes
   Simplified device maintenance

 

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