About, and the limits

This site joins two public registers that share no common identifier. The join is made on company names, normalised on both sides the same way: uppercased, legal forms removed, then reduced to letters and digits.

⚠️ What can go wrong, measured

On a sample of ten unmatched manufacturers, checked one by one, nine were genuinely absent from the U.S. register and one was written differently — Labsystems Diagnostics Oy against LABSYSTEMS DIAGNOSTICS. A two-state list would have been 10 % wrong. That is why there is a third state, and why we never write “not registered” when we mean “not found”.

⚠️ Why “not found” is never “not sold”

Every page on this site can say that a manufacturer was not found in a register. None of them says it is absent from that market, and the difference is not a legal precaution — it is what the data supports.

• A distributor may carry the product. A European manufacturer often reaches the United States through an importer registered under its own name. Nothing in either register links the two.
• The corporate name may be written differently. That is what the third state is for, and it still misses some.
• Canada does not list Class I devices at all. They need no licence there. A manufacturer of Class I devices only is absent from the Canadian register while selling in Canada perfectly lawfully. This is a limit of the source, and it is the reason the Canadian column is never read as a market statement.

We measured the first case where we could: among the European manufacturers not found in the U.S. establishment register whose devices carry a numeric GTIN, 2.6 % have at least one device that does appear in the U.S. device database. ⚠️ That is a lower bound, not the error rate: it only catches companies selling the same device identifier on both sides. A hand-check of twenty cases during design suggested a broader figure of around 15 % once different identifiers are counted — a small sample, and we publish both numbers rather than the one that flatters us.

What this is not

• Not a legal or regulatory determination. For that, consult the registers themselves.
• Not proof of market presence or absence — only of registration under a matching name.
• Not affiliated with the European Commission, the FDA or Health Canada.

Corrections

If a page is wrong about your company, tell us and we will fix it — the underlying registers are not ours to change, but our matching is.