A single HTML file that runs in your browser — offline, secure, and built around the full GS1 UDI structure required by MDR 2017/745 and IVDR 2017/746.
Structured UDI/GS1 mode with live GS1 string preview
DataMatrix output with AIDC + HRI composite label
Batch mode — process hundreds of codes from a CSV
If you're a small or mid-size medical device manufacturer navigating MDR or IVDR compliance, you know the challenge: enterprise software is priced for enterprise budgets. This tool was built by a regulatory consultant who works with medical device companies every day. It handles the exact UDI structure that MDR Annex VI requires — without the overhead.
No subscription. No renewal. No user limits.
You get the file. You use it as long as you need it.
Secure checkout powered by Lemon Squeezy
No. It generates GS1-compliant barcode structures following the Application Identifier definitions and MDR Annex VI requirements. Your final UDI must be validated as part of your technical documentation and QMS process.
Yes. Once downloaded, the file runs entirely in your browser with no internet connection needed. Your data never leaves your device.
The batch mode accepts a CSV file and exports all codes as a ZIP archive, with optional HRI labels for each one.
Yes. One purchase, no restrictions on how many devices you use it on.