European device manufacturers across three registers

Europe publishes who manufactures. The United States publishes who has registered an establishment. Canada publishes who holds a device licence. None of the three can publish this table, because none of them sees the other two.

Profile	United States	Canada	Manufacturers	Share
Neither register	absent	absent	3 327	69.04 %
United States only	apparie	absent	645	13.38 %
Both markets	apparie	apparie	525	10.89 %
Canada only	absent	apparie	141	2.93 %
Needs checking	voisin	absent	88	1.83 %
Needs checking	voisin	voisin	37	0.77 %
Needs checking	absent	voisin	22	0.46 %
Needs checking	voisin	apparie	17	0.35 %
Needs checking	apparie	voisin	17	0.35 %

What the four profiles mean commercially

3 327 manufacturers appear in neither register. Some have never sought a market outside Europe; others reach one through a distributor registered under its own name. The two look identical from here, and we do not guess which is which.

141 hold a Canadian licence but were not found in the U.S. register. This is the smallest group and the most specific one: these companies have already carried a device through a non-European regulator, and have not done so for the largest market. Whatever stopped them, it was not inexperience.

525 are present in both.

⚠ The two registers do not cover the same ground. The U.S. register lists establishments of every class; Health Canada lists only Class II, III and IV devices, because Class I needs no licence there. A manufacturer of Class I devices only is therefore absent from the Canadian register without being absent from the Canadian market. Comparing the two columns as if they measured the same thing would be wrong, and we say so rather than let the table imply it.

⚠ Names, not identifiers. The three registers share no common key. Every match here is made on company names, which is why a third state exists — see what this site does not settle.

The data behind these pages

The full comparison — every European manufacturer, its three-state FDA status, the matched FDA number where there is one, device counts and risk classes — is available as a file. So is the list of the 3 490 manufacturers not found in the U.S. register.

Pro access and prices → What the dataset contains →