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 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.

As of September 24, 2015, all implantable, life-supporting/life-sustaining medical devices must bear a UDI label.

The next deadline, September 24, 2016, refers to Class III devices required to be labeled with a UDI, as they must bear a UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use. Also, the labels and packages of Class II medical devices must bear a UDI, and data must be submitted to the FDA's Global Unique Device Identification Database (GUDID). For more information on the compliance dates, visit the FDA website here.

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.

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.

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.

UDI label software 

UDI Label in TEKLYNX Software

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