Registration identifies the facility; listing identifies which specific devices that facility makes or distributes. Both are required, and neither substitutes for the other.
21 CFR Part 807, Subpart B
What people get wrong
A company can register its establishment and still fail to list a specific device, and vice versa — they're tracked and enforced separately, and both must be renewed annually during the same October–December window. Registration alone does not mean FDA has reviewed or cleared anything; it's purely an administrative step, and treating it as a stamp of approval is a common — and incorrect — assumption.
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