Check that your GS1 UDI-DI is correctly structured and ready for EUDAMED submission. Validates format, Application Identifiers and check digits.
(01)
GTIN / UDI-DI
14 digits - mandatory for EUDAMED
(10)
Batch / Lot Number
Up to 20 alphanumeric characters
(17)
Expiry Date
6 digits: YYMMDD format
(21)
Serial Number
(11)
Production Date
(8012)
Software Version
EUDAMED requirement
The UDI-DI (GTIN-14) is mandatory for all device registrations in EUDAMED. It must be a valid GS1 GTIN with the correct check digits and must be registered with a GS1 issuing entity.
Understanding how GS1 identifiers relate to EUDAMED device registration under MDR and IVDR.
The Basic UDI-DI (also called BUDI-DI) is a unique identifier specific to a medical device product family (or model/group) under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). This the key linking element in EUDAMED.
The UDI-DI (Device Identifier) is the fixed portion of a UDI that identifies the labelled version of a device. Each unique device configuration requires its own UDI-DI in EUDAMED.
The UDI-PI (Production Identifier) is the variable portion of a UDI. It includes batch/lot number, serial number, expiry date and manufacturing date — but is NOT registered directly in EUDAMED.
Our team can validate your full EUDAMED dataset and handle bulk upload or M2M submission.
We use cookies to improve your experience on our site. By continuing to use this site you consent to our use of cookies in accordance with our Privacy Policy.
