FDA registration for Class 1 Medical Device?

[PurpleTurtle]

Hello friends, company I work for is a iso13485 contract manufacturer. We have been contracted to build a class 1 medical device and im not sure whether we need to register with the FDA for that particular product. Reading over the FDA requirements, its not clear to me whether we need to or not. For product flow, we will manufacture the product and ship it to our customer where they will finalize packaging to the end user.

What are your thoughts?