What is the difference between Basic UDI-DI and UDI-DI?

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M

Marcelo

Inactive Registered Visitor
#2
#2
The Basic UDI-DI is the ID for the product (or group of products) under EU rules. It serves, in principle, only for this purpose (for example, it's not used in the supply chain. It's used for regulatory traceability). It is, for example, the key to Eudamed for the product (or group of products).
 
D

duinyk

Involved In Discussions
#4
#4
which National Competent Authorities can issue or appoint the SRN in EUDAMED for a US manufacturer?

And I understand GS1 can issue EU UDI's right?
Thanks
 
A

Asia78

Involved In Discussions
#6
#6
duinyk said:
which National Competent Authorities can issue or appoint the SRN in EUDAMED for a US manufacturer?

And I understand GS1 can issue EU UDI's right?
Thanks
Click to expand...
Yes, GS1 can issue the UDIs.
EC Selects Four UDI Issuing Entities

Regarding the SRN: in Germany, in the website of the competent authority I read the message that the SRN will be given automatically at the moment of the registration in the database, when ready. I am not sure of what will be for non European manufacturers, I guess it will also be given automatically.
 
R

Richard Houlihan

Registered
#7
#7
The SRN is generated by EUDAMED once the CA validates your application. For non-eu your EU Authorised representative must be registered first as they have to validate your application before it goes to the CA and then you receive your SRN.
 
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