Medical and Surgical UDI Marking
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