Iskra Medical, d.o.o., raziskave in razvoj na področju medicinske opreme in kozmetike
SI-MF-000006345 · Slovenia · Ljubljana
Iskra Medical, d.o.o., raziskave in razvoj na področju medicinske opreme in kozmetike is registered in the European database on medical devices as a manufacturer, with 31 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 31 |
|---|
Most frequent device types declared: 31 Models from MDR Certificate 2023-MDR/QS-009/D.
Among these devices, 31 are declared active.
Devices declared under this manufacturer
- FMS 4
- FMS CARE BF
- FMS Care
- FMS Duo
- FMS Former prestige
- FMS Uno
- MAG GYM
- Magneto STYM Quattro
- T CARE
- TESLA Care prestige
- TESLA Former II
- TESLA Former Quattro
Showing 12 of 31 declared devices.
Catalogue references include MS004, MS006, MS008, MS012, MS016, MS019.
European nomenclature codes declared: Z120606.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 31 |
| Country of registration | Slovenia |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 31 |
|---|---|
| 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. Iskra Medical, d.o.o., raziskave in razvoj na področju medicinske opreme in kozmetike was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
2023-MDR/QS-009/D | reissued | 2031-05-15 |