UDI labelling for medical device manufacturers
A UDI combines a device's identity and its production data in one carrier. Printing it correctly, reading it back and matching it to the record is the basis of traceability in the field.
01
What makes it hard in practice
Product variety
Many products in different sizes and packaging levels on the same line, each needing the right device identifier and label template.
Lot and serial side by side
Some products are tracked by lot, others by serial number; production identifiers must be chosen correctly per product.
Record consistency
What is printed on the label must match the product and production records in regulatory databases such as EUDAMED, GUDID or Türkiye's ÜTS.
02
Our approach
- AFrom master data to labelDevice identifiers and product data come from a single master record; the label template is chosen by product and packaging level.
- BPrinting and verificationDirect communication with industrial printers and closed-loop camera reading; check digit, date format and field structure are checked on every label.
- CAudit trailWho printed which lot and when; changes are recorded with their reason and can be presented in an audit.
03
Compliance frame
- GS1 DataMatrix / GS1-128
- UDI
- EUDAMED / GUDID / ÜTS
- FDA 21 CFR Part 11
FAQ
- What does a UDI label contain?
- A device identifier (in the GS1 system a GTIN, AI 01) and at least one production identifier: lot (10), serial number (21), production date (11) or expiration date (17). Which ones apply depends on how the product is tracked.
- Does it work with our existing label printers?
- It communicates directly with industrial label printers over ZPL/EPL and TCP/IP; the models on your line are confirmed during discovery.
- How can I check a printed label?
- Paste the code content into our free GS1 barcode decoder; for UDI it also checks that a device identifier and a production identifier are present.
A discovery call for your product range
Let's talk about your products and packaging levels, label printers and registration processes, and map the end-to-end flow from label to record together.