UDI Compliant Marking

Unique Device Identification (UDI) is a global standard system for identification in medical manufacturing. While the standard applies to many products and packaging, we focus here on the UDI marking requirements to make permanent marks on metal implantable devices and reusable tools.

What constitutes a UDI mark?

• UDI marks are directly marked on the part or device
• UDI marks need to have high contrast and visible from a wide viewing angle to be machine and human readable. This is best achieved with a dark, black mark.
• UDI marks are permanent and non-fading, sometimes they also need to be corrosion-resistant.
• For implantable devices and surgical tools, it is necessary that the UDI mark is not etched into the surface creating areas where bacteria could form.
• UDI compliant marks consist of both machine-readable code (barcode or 2D data matrix code) and human-readable code (alphanumeric).

Do all medical devices need UDI marks?

All implantable and reusable medical devices for sale in the United States must bear a UDI code. The European market is also planning for mandatory UDI labeling with a phased approach to implementation between 2021 and 2027.  The goal is to achieve a global, standardized UDI system. Find detailed information on the FDA and European Commission websites.

What solutions does AMADA WELD TECH offer for making UDI marks?

A number of laser marking technologies have been used to achieve black marking. Depending on the part, material, and mark requirements, this could be either a fiber laser, UV laser or picosecond laser. The following outlines our standard products and systems:

The WL-P300A is a Class 1 workstation optimized for black marking. Integrated with a picosecond IR  or fiber laser, it is ideal for making permanent,bacteria and corrosion resistant, machine-readable, dark black marks.

The WL-100A is a compact desktop fiber laser marking machine geared for low volume production and R&D environments over a wide range of industries. Though best suited as a laser marking machine for metal, WL-100A can also mark plastics and ceramics.

The LM-F family of fiber lasers are rugged, cutting-edge machines designed to address a wide range of metal laser marking applications. The lasers are designed with multiple integration options to accommodate standalone operation, full production automation, or prototype development.

Ask us also about bespoke, integrated systems designed and programmed for your parts!

Further Reading

For more information on what AMADA WELD TECH is doing with respect to UDI compliant marking see:

• Application examples: Black Marking
• Blog: Corrosion Resistant Marking: Why You Should be Using a Picosecond IR Laser for Black Laser Marking Applications
• Application bulletin: Black Picosecond Marking
• Whitepaper: Corrosion Resistant Dark Marking