HIBCC’s UDI & Labeling Resource Center
Getting Started: HIBCC’s Guide to UDI Compliance
Step 1: Apply for a Labeler Identification Code (LIC)
The FDA and European Commission have identified the Health Industry Bar Code Supplier Labeling Standard (HIBC SLS) as a data standard for UDI. The FDA and EU regulations require a device identifier, which includes a Company Prefix, such as the HIBC LIC.
Step 2: Download the HIBC Supplier Labeling Standard (SLS)
The HIBC SLS 2.6 is your guide to creating bar codes and UDIs that satisfy global regulatory requirements.
Step 3: Create a login to the HIBC UDI-Builder
Generate a UDI compliant HIBCC data string and bar code. This tool will allow you to create, calculate, confirm, and collect UDIs. The HIBC UDI-Builder’s intuitive, easy-to-use design assists users in quickly creating globally-accepted UDIs for their products.
HIBCC UDI Useful Documents
- Download the Mod 43 Check Character Calculation Guide
- How to Use HIBCC Date Formats for UDI
- HIBCC’s Guide to Understanding Unit of Measure
- HIBCC’s Guide to GUDID Device Identifiers
- HIBCC UDI Compliant Label Examples
- EDI Transaction Mapping Guide
- EDI Transaction Best Practices
- GUDID Best Practices Guide