FDA and GS1 UDI Laser Marking

Implementing FDA UDI marking into your Manufacturing Process?  We can help!

 

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Traceability is imperative for medical and surgical devices and implants.  TYKMA Electrox has years of experience in helping medical manufacturers implement traceability systems.

Recently, the United States Food and Drug Administration (FDA) and the European Commission have passed legislation for UDI or Unique Device Identification.  This will require certain types of medical devices and packaging to be marked with a specifically formatted machine readable code (2D or Linear Barcode).

Manufacturers will be required to encode several pieces of data into these machine readable codes including their Device Identifier (DI) or GS1 Global Trade Item Number® (GTIN®) as well as various production or application identifiers such as batch numbers, date codes, expiry dates and serial numbers.

TYKMA Electrox can offer the following to manufacturers requiring direct part marking with UDI:

  • Application and Implementation Assistance
  • UDI Ready Laser Engraving Machines and Software
  • Cognex Dataman™ Readers and Software with UDI Verification Capability
  • Custom Software Solutions for Factory Automation and Data Handshaking

About TYKMA Electrox

We are specialists in industrial laser marking and engraving systems. Our number one focus is the relationship with our customers as we aim to make things simple. From the initial contact through the installation of your laser system and beyond, we strive to provide a personalized consultative approach to solving your application.

Utilizing the latest in MOPA fiber laser technology, our machines offer high end design and are packed with cutting edge features backed with the best warranty in the industry. We can mark a variety of substrates, from all metals to most plastics, from anodized to carbide and more.

Contact us today to learn how TYKMA’s expertise and experience can help solve your application.