Can I have 1 Medical Device with 3 different names?

D

dajobimi

#11
Hi,

I just crossed the same issue, when our marketing team decided to launch a new name for our
product. I always assumed that the FURLS database (that allows you to list your devices) is
designed to allow you to add new proprietary names. It has a dialog, literally saying:
"Proprietary Names
Enter any proprietary or brand names that your product is distributed under, then click Continue."

It even allows you to Remove Names.

What else could the purpose of this screen be, if you cannot have different names??

Dajobimi.
 
Elsmar Forum Sponsor
M

MIREGMGR

#12
(...) the FURLS database (that allows you to list your devices) is designed to allow you to add new proprietary names. It has a dialog, literally saying: "Proprietary Names -- Enter any proprietary or brand names that your product is distributed under, then click Continue." It even allows you to Remove Names. What else could the purpose of this screen be, if you cannot have different names?
I'm quite sure multiple brand names are allowable. I can think of many examples in the device marketplace; as noted the FDA's own control systems provide for multiple names; and, there is no legal provision or written guidance that even addresses the question otherwise. My assumption is that a communication problem or individual error was responsible for the apparent verbal guidance to the contrary.
 

fialor

Involved In Discussions
#13
I am aware this thread is pretty old. But I have similar question - this time under EU CE marking.
Can a business have multiple brand names for the same CE marked device?
Each brand distributed by a different distributor.
Thanks.
 

Sicco

Involved In Discussions
#14
I am aware this thread is pretty old. But I have similar question - this time under EU CE marking.
Can a business have multiple brand names for the same CE marked device?
Each brand distributed by a different distributor.
Thanks.
Yes it is possible, but you have to communicate it with your NB and have all those names stated in EC Certificate
 
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