UDI Compliance

Barcode Printing and Variable Data for Ensuring Compliance with FDA's UDI Mandate on Medical Devices

Complying with the FDA's UDI mandate is crucial for medical device companies and Greydon has some excellent solutions for ensuring your products are correctly labeled. Greydon offers UDI printing systems that can print barcodes that are compliant to both GS1 and HIBCC standards.

The UDI rule requires a unique machine-readable identifier is added to each level of packaging (and in some cases directly on the device itself) and Greydon's flexo and digital printers allow printing of UDI data, as well as other information, directly onto the packaging. An additional benefit, the Greydon printer can often print the complete package, eliminating the need to purchase and manage an inventory of pre-printed packaging material.

Genesis is Greydon's digital printer for the medical device industry. It is able to print variable data (date, lot and other text, along with graphics and UDI barcodes) onto films, foils and Tyvek, in real-time, without the need for printing plates.

Greydon genesis

Genesis is available in versions for single color, two-color or full CMYK printing and can be integrated into any horizontal packaging machine.

Greydon's Flexographic printers are designed to produce the best possible print at minimum cost. These printers can be configured as single color or two-color and use quick change photo-polymer print plates to create the image on the packaging.

Flexographic Printer

The variable data, including UDI barcodes, is printed with a secondary digital printer. This can be a thermal transfer printer, HP based TIJ inkjet or a Genesis digital printer.

ProMach's Labeling & Coding group offers a variety of UDI printing systems that can handle every level of UDI labeling, including direct part marking on products, primary packaging, secondary packaging and pallet labeling.

To learn more, see our eBook on UDI compliance to get more info on complying with the FDA's rule and the print technologies that are available to help.