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 has a similarly named entry in the FDA register that we have not verified.
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.
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 | Similar name found — unverified |
|---|---|
| Matched entry | ISKRA MEDICAL D O O (SI) · FDA 3007766590 |
| Devices in EUDAMED | 31 |
| Country of registration | Slovenia |
⚠️ A similar name exists in the FDA register. We do not assert that it is the same company — the two registers share no common identifier, and a name alone is not proof. This entry needs a human check.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
2023-MDR/QS-009/D | reissued | 2031-05-15 |