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Advena Guidance on UDI Codes

We must agree, the terminology used doesn’t help. Basic UDI-DI, UDI-DI, UDI-PI and UDI all sound very similar and could pave the way for confusion.

Put simply, the Basic UDI-DI is primary alphanumeric identifier of a group of devices with the same intended purpose, classification, essential design and manufacturing characteristics, which does not appear on the labelling. Think of this as the “root” identifier.

On the other hand, the UDI-DI is a numeric identifier which refers to a specific product. Therefore, investigating a UDI-DI will lead you to one particular device variant, whilst a Basic UDI-DI may lead you to many UDI-DI.

A guidance document has been drafted by Advena in order to help manufacturers distinguish between these codes, as well as guidance on how to generate and use this codes appropriately.

The guidance document can be accessed using the following link.

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