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Is the contract mfg. mentioned in legal manufacturer EC certificate?

#1
1 / Legal mfg. in USA
2 / Contract mfg. in China
3 / they have authorized rep. in EU
4 / the legal have the EC certificate but the contract manufacturer does not mentioned on the EC facilities.

So the question, Is the contract mfg. must mentioned in legal manufacturer EC certificate?
Please advice.
 
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CharlieUK

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#4
I'm not familiar with the IVD
The "Factory" not generally detailed on EU Notified Body Certificates - the manufacturer and their QA process is part of the compliance process, but that is normally all.
The "manufacturer" is the company that brands the product with their name, and as they are outside the EU, they need a representative that is inside the EU
You must tell the NB if you change factory
 
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