GTIN
Colloquially, many know GTIN as a barcode, but technically, GTIN is the number found beneath the barcode symbol itself, and can therefore also be used for other technologies such as 2D barcodes and RFID tags.
Colloquially, many know GTIN as a barcode, but technically, GTIN is the number found beneath the barcode symbol itself, and can therefore also be used for other technologies such as 2D barcodes and RFID tags.
Are you ready for the Eudamed requirements as of May 28, 2026?
GS1 UDI Link gives you one secure, validated channel to all regulatory databases — directly from your existing GDSN flow.
As of 28 May 2026, reporting up to 100 UDI attributes per product to the EU’s EUDAMED database will become mandatory, and the U.S. (GUDID) already has reporting requirements in place.
Many manufacturers are already struggling with multiple systems, manual uploads, and the risk of errors - all of which are costly and time-consuming.
GS1 UDI Link has been developed by several GS1 organizations. The module connects your GS1Trade Sync data pool directly to EUDAMED and also includes an FDA GUDID connection. From spring 2026, it will also be possible to submit data to SWISSDAMED, with additional medical device registries (AusUDID, SAUDI-DI, etc.) being added continuously.
EU legislation requires you to register your medical devices in the European database EUDAMED if you manufacture products covered by the EU Medical Device Regulations (MDR and IVDR).
The deadline for submitting data to EUDAMED is 28 November 2026 for products placed on the market before 28 May 2026.
If you have many products to register, the process can be time-consuming and complex. GS1 can help streamline your submission to EUDAMED. Through GS1Trade Sync, you can register your product data and share it with both customers and authorities - including EUDAMED - using GS1 UDI Link.
Mandatory use for new products
Transition for UDI registration ends
Certificates transition ends
We have created two short value propositions to give you a quick overview of the benefits of UDI Link. One is aimed at management and highlights the value for the business, while the other is tailored to regulatory teams and shows how UDI compliance becomes easier in daily operations.
You can download them below.
De to guidelines hjælper virksomheder med at komme sikkert og effektivt i gang med UDI-registrering via GS1 UDI-Link til henholdsvis EUDAMED og swissdamed. Dokumenterne guider brugeren gennem hele processen – fra onboarding og opsætning til test, validering, live-indberetning og fejlhåndtering.
Guidelines beskriver blandt andet:
For brugere af GS1 UDI-Link giver guidelines et praktisk og struktureret overblik, som reducerer risikoen for fejl og gør det lettere at opfylde regulatoriske krav i både EU og Schweiz.
Tested alongside leading manufacturers and GS1 organizations in several countries.
GS1 Denmark offer you advice on everything from UDI generation to data mapping.
GS1 UDI Link will be expanded to additional countries as regulatory requirements are introduced.
Data submission to medical device registries
With GS1 UDI Link, you can submit your data to the relevant medical device registries. The pricing includes two UDI connections, covering data submission to both EUDAMED (EU) and GUDID (USA).Over time, additional connections will become available, enabling you to submit data to other registries, such as those in Switzerland, China, Korea, and Australia.
Prices for data suppliers
Annual turnover < 5 Mio Euro
50.000 DKK/YEAR
Annual turnover < 20 Mio Euro
85.000 DKK/YEAR
Annual turnover < 100 Mio Euro
130,000 DKK/YEAR
Annual turnover < 500 Mio Euro
160,000 DKK/YEAR
Annual turnover > 500 Mio Euro
Price on request
In addition, a one-time fee is charged at the start
Annual turnover < 5 Mio Euro
15.000 DKK
Annual turnover < 20 Mio Euro
20.000 DKK
Annual turnover < 100 Mio Euro
25.000 DKK
Annual turnover < 500 Mio Euro
30.000 DKK
Annual turnover > 500 Mio Euro
30.000 DKK
Nedenfor finder du nogle af de spørgsmål, vi allerede har fået omkring denne service - og de svar vi har givet.
Måske det også er noget af det, du søger. Ellers er du velkommen til at kontakte os.
From January 2026, you can use GS1 UDI Link to submit data to EUDAMED.From January 2026, you can use GS1 UDI Link to submit data to EUDAMED.GS1 UDI Link
If you would like to use GS1 UDI Link and get started, please fill out the form and we will contact you to arrange a kick off meeting.
