UDI Label Software

Regulation: Unique Device Identification (UDI)

Industry: Healthcare

udi label softwareMany organizations within the healthcare industry face challenges ensuring their barcode labeling systems are compliant with various regulations. 

The U.S. Food and Drug Administration (FDA) requires that all medical devices distributed in the United States be labeled with a Unique Device Identifier (UDI), which is comprised of a unique numeric or alphanumeric code that is used to mark and identify medical devices within the supply chain.

With over 80 barcode types and pre-configured samples, TEKLYNX UDI label software is CFR Part 11 compliant, and is capable of printing GS1 and HIBC required to generate the AIDC technology labels for UDI compliance, with support for thermal and thermal transfer printers. 

Read the case study on how TEKLYNX CENTRAL CFR helped medical device packaging and outsourcing solutions provider, Quality Tech Services (QTS), increase efficiency by 40% and become UDI compliant. The case study is only available in English.

Download a free recording of our webinar, Get Ready for UDI: The Final Rule, Impact, and Steps to Comply, hosted by TEKLYNX Label Design Product Manager, David Kane, and industry expert Dan O’Leary, President of Ombu Enterprises, LLC. The webinar is only available in English.

Download the free eBook: Are You Ready for UDI? 9 Steps to Become UDI Compliant, to learn about the necessary steps you need to take to become compliant. The eBook is only available in English.

UDI label software

UDI Label in TEKLYNX Software

Request a free demonstration of TEKLYNX Enterprise Label Management Solutions for UDI labeling today!