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 2V, DK50 2V/50, DK50 2V/50/M, DK50 2VS/M, DK50 2x2V/110/M.
Among these devices, 922 are declared active.
Devices declared under this manufacturer
- DK50 2V
- DK50 2V/50
- DK50 2V/50/M
- DK50 2V/M MOBILE
- DK50 2VS/M
- DK50 2x2V/110S/M
- DK50 2x4VR/110/M
- DK50 2x4VR/110S/M
- DK50 4VR/50
- DK50 4VR/50S/M
- DK50 DE
- DK50 DI
Showing 12 of 922 declared devices.
Catalogue references include 403201101-300, 403201101-301, 4032021A1-302, 4041020A6-400, 4062010B5-003, 430402009-301.
European nomenclature codes declared: Q0199, R9099, V0899, Q019001.
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 |
Device-level evidence
| Devices with a numeric GTIN | 922 |
|---|---|
| Found in the U.S. device database | 18 |
| Share | 2.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | EKOM SPOL S.R.O. |
North American profile: Both markets. EKOM spol. s r.o. is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
C683401 | issued | 2031-06-17 |