EKOM spol. s r.o.
SK-MF-000002069 · Slovakia · Piešťany
EKOM spol. s r.o. is registered in the European database on medical devices as a manufacturer, with 922 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 763 |
|---|---|
| Class IIb | 159 |
Most frequent device types declared: DK50 DS, DK50 DE, DK50 2x2V/110/M, DK50 2x2V/110S/M, DK50 2V/50/M.
Among these devices, 922 are declared active.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | EKOM SPOL. S R.O. (SK) · FDA 3005245901 |
| Devices in EUDAMED | 922 |
| Country of registration | Slovakia |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
C683401 | issued | 2031-06-17 |