Which European device manufacturers are registered in the United States?
Type at least three letters. 4 837 European manufacturers with five or more devices declared.
Two public registers, no shared identifier, and nobody joins them. This site compares 4 837 European manufacturers from the EU medical device database against the U.S. FDA establishment register, and publishes what the comparison finds — including what it cannot settle.
| Matched in the FDA register | 1 187 | 24.5 % |
|---|---|---|
| Not found | 3 490 | 72.2 % |
| Similar name, unverified | 142 | 2.9 % |
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.
By country
| Country | Manufacturers | Not found in FDA | Share |
|---|---|---|---|
| Germany | 1 071 | 706 | 66 % |
| Italy | 805 | 657 | 82 % |
| France | 491 | 353 | 72 % |
| United Kingdom | 395 | 220 | 56 % |
| Poland | 279 | 265 | 95 % |
| Spain | 256 | 193 | 75 % |
| Netherlands | 214 | 169 | 79 % |
| Switzerland | 194 | 93 | 48 % |
| Sweden | 163 | 89 | 55 % |
| Finland | 131 | 97 | 74 % |
| Denmark | 113 | 76 | 67 % |
| Belgium | 106 | 72 | 68 % |
| Czechia | 97 | 85 | 88 % |
| Austria | 79 | 53 | 67 % |
| Ireland | 65 | 35 | 54 % |
| Portugal | 58 | 56 | 97 % |
| Hungary | 54 | 52 | 96 % |
| Romania | 46 | 46 | 100 % |
| Greece | 45 | 26 | 58 % |
| Slovakia | 43 | 38 | 88 % |
| Norway | 31 | 23 | 74 % |
| Slovenia | 23 | 23 | 100 % |
| Croatia | 18 | 17 | 94 % |
| Lithuania | 17 | 15 | 88 % |
| Bulgaria | 10 | 9 | 90 % |
| Liechtenstein | 10 | 2 | 20 % |
| Latvia | 8 | 7 | 88 % |
| Estonia | 5 | 5 | 100 % |
| Cyprus | 3 | 3 | 100 % |
| Iceland | 3 | 2 | 67 % |
| Luxembourg | 2 | 2 | 100 % |
| Malta | 2 | 1 | 50 % |
What this is for
A manufacturer registered in Europe but absent from the U.S. register has not entered the American market — or has entered it under another name. For anyone selling regulatory, distribution or market-access services, that distinction is the difference between a prospect and a mistake.