SRN, Basic UDI, Legal Manufacturer

Gary Zhang

Registered
Hello all, does anyone know if we change the legal manufacture address from A(America) to B(Europe), but same brand, same company, same product, same OEM(From Asia), do we need to obtain a new manufacturer SRN and a new basic UDI?
 

monoj mon

Trusted Information Resource
The very first thing in the SRN is the country code, and changing the country will definitely call for a new SRN. Basic UDI-DI is your internal thing and mostly related to your device, if you haven't used it officially anywhere yet then I guess you can keep it same. For the Basic UDI-DI part, I will recommend you to talk to your notified body and/or EU rep. (if any).
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Gary Zhang

Registered
The very first thing in the SRN is the country code, and changing the country will definitely call for a new SRN. Basic UDI-DI is your internal thing and mostly related to your device, if you haven't used it officially anywhere yet then I guess you can keep it same. For the Basic UDI-DI part, I will recommend you to talk to your notified body and/or EU rep. (if any).

Thank you very much for the comment, Monoj. In our case, it's an OEM product, we just change the legal manufacturer address from one country to another country, do you still think it was the case you thought of? Thank you again!
 

monoj mon

Trusted Information Resource
In our case, it's an OEM product
Does that mean you are the OEM? SRN is issued to the facility, not to the device. If your address is constant then I believed your SRN won't change. But for the Basic UDI-DI part my comment will remain same as previous.
 

Gary Zhang

Registered
Does that mean you are the OEM? SRN is issued to the facility, not to the device. If your address is constant then I believed your SRN won't change. But for the Basic UDI-DI part my comment will remain same as previous.
No, we are not, but we are the legal manufacturer, the brand owner. In this case, we just close a division in America, and now move to Europe, but the OEM is in China and won't get changed. In the Legal Manufacturer, the company's name won't change, but the address will change, and in the label, the address shows just below the organization's name.
 
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