EM EXACT, S.A.
ES-MF-000010830 · Spain · Ripollet
EM EXACT, S.A. is registered in the European database on medical devices as a manufacturer, with 2 622 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 309 |
|---|---|
| Class IIb | 2 313 |
Most frequent device types declared: LOC, PPR, PSD, PTA, PTB.
Among these devices, 2 are declared sterile, 2 313 implantable, 288 reusable.
Catalogue references include 25019_EM, 25022_EM, 6639, BHS03117, IP9026N, LAN-BIRA1815T.
European nomenclature codes declared: P01020180, Q010499, Q010207, Q010280.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 2 622 |
| Country of registration | Spain |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 2 622 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. EM EXACT, S.A. was not found in either the U.S. or the Canadian register.