UDI (Unique Device Identification) is a globally standardized code system for medical devices, consisting of a Device Identifier (DI) and a Production Identifier (PI), enabling full traceability throughout the device's lifecycle
Why use udi code?
Key Benefits:
- Enhanced Traceability: Tracks a device from production to usage, improving recall efficiency and patient safety.
- Regulatory Compliance: Meets international regulations (e.g., FDA, EU MDR) for market access and supply chain management.
- Improved Data Sharing: Standardized coding enables seamless data exchange among hospitals, suppliers, and regulators, reducing errors and increasing efficiency.
Application
Used on medical device labels, packaging, and databases (e.g., surgical tools, implants).
Background and trend
Originally proposed by the US FDA, it has now become an internationally recognized medical device labeling system. China has gradually implemented it since 2019, covering Class III and some Class II medical devices.
Why Use UV/PIJ Inkjet Printing for UDI Codes?
- High Durability
- Precision & Compliance
- Versatility
- Efficiency
In China, more and more medical device manufacturers are adopting UV inkjet printers for UDI code marking, delivering high-quality prints at fast speeds to significantly enhance overall production efficiency.
Hope this term's sharing is helpful and useful to all of you.
-Edited by Gloria
2025.7.31
