A registration number that identifies a group of medical devices with the same purpose, risk class and comparable design and manufacturing functions. In general, a Basic UDI-DI consists of four elements:
- A specific start for an issuing body (eg GS1 codes start with “01”)
- Manufacturer code
- Product group code
- Check digit
Basic UDI-DI is used to register the units in EUDAMED and must be referred to in relevant documents (ie in the certificates and technical documentation including operating instructions). However, it must not be stated either on the product packaging or on the product itself. The manufacturers of medical devices are responsible for maintaining a mapping between the Basic UDI-DI and all associated (underlying) UDI-DIs.