Hi all, I need your input on this subject.
We have a class I medical devices which can be sold in US, and the medical devices have registered number on the instrument. We have a tracking method to see where the instrument (serial number) goes and also if the instrument can be as a medical device or RUO. We haven't sell the medical device as an RUO in US. We sell only as a medical device (class I) in US. My question is that can we sell the medical device only by tracking the device as RUO without changing the label on the instrument (having the class I registered number on the instrument)? We do obtain an agreement letter with every customer whether they want to purchase as a medical device or RUO.
Ishii