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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.
In the instructions below you will find descriptions of how to form a UDI and Basic UDI-DI for medical devices. A product's UDI consists of the product's device identifier (DI) and the product's production identifiers (PIs).
The EU Medical Devices Regulation requires products to have a Basic UDI-DI and be labelled with a UDI. That is, with a unique barcode containing the UDI-DI of the product as well as dynamic information such as batch number and expiration date.
We at GS1 can help your company meet the requirements and thus become UDI compliant.
A product's UDI consists of the product's device identifier (DI) and the product's production identifiers (PIs).
In order to acquire the necessary services and numbers, your company must first be a member of GS1 Denmark. Become a member here.
For the formation of UDI-DI you will need a GS1ID. You can buy a GS1ID to GTIN-13, which is what is used to form a UDI-DI via With GS1.
When choosing the number of identification numbers, it is important to pay attention to the fact that different variants of the products must have their own number. Examples of different variations:
Find prices for membership and GS1ID
The UDI-DI you must form consists of three parts:
The check digit is calculated from the previous digits.
Use our check digit calculator to calculate your check digit
The total number is 13 digits, i.e. how long the reference number should be depends on the length of your GS1ID. In the UDI-DI context, the final number must be 14 digits, so once you have formed the 13 digit number, you must prefix a 0 so that the final number is 14 digits.
The following is a short video explaining Basic UDI-DI and its structure.
Basic UDI-DI is the main key in the EU database EUDAMED and on relevant documentation (e.g. certificates, declaration of conformity, technical documentation and summary of safety and clinical performance). Basic UDI-DI identifies not one specific product, but a cluster of products with the same essential characteristics and connects entities with the same intended purpose, risk class, and essential design and manufacturing characteristics.
It is independent/separate from the packaging/labeling of the device, and it does not have to be stated therein.
An example of products that could have the same Basic UDI-DI could be gloves, which are available in several different sizes (small, medium and large). These gloves have the same characteristics and purpose and must therefore have the same Basic UDI-DI. But why is it a good idea? It is because it provides a good overview of products with the same characteristics, which can be used in a possible recall situation. Because if there is a problem with gloves in size small, there is a risk that the same problem is present for size medium and large.
To be able to form a Basic UDI-DI you need a membership with GS1 Denmark. When you sign up under With GS1 and buy a GS1LEGITIMATION identification number for GTIN-13 to form your company's product UDIs, you get a GS1ID, and this prefix you must also apply to form the Basic UDI diet.
A Basic UDI-DI consists of three parts:
A Basic UDI-DI is called in GS1 language a Global Model Number. Calculate the control character pair.
A Basic UDI-DI can be alphanumeric, and it must max out at 25 characters.
Read more about Basic UDI-DI in this English PDF
We offer our members free advice and courses. For example, you can get a basic course in UDI generation for medical devices.
Do you still need help? Reach out to our support team. We are always ready to help.
