IGEA S.p.A.
IT-MF-000011242 · Italy · Carpi
IGEA S.p.A. is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 8 |
|---|
Among these devices, 6 are declared sterile, 8 active.
Devices declared under this manufacturer
- EPSA Series
- I-NIC
- JoCare
Catalogue references include IG0E040, IG0E050, IG0E070, IG0E080, IG0E090, IG4170V.
European nomenclature codes declared: K0299, Z12139099, Z12109099.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 8 |
| Country of registration | Italy |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 8 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | IGEA S.P.A. |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 1 |
| First licensed | 2025-05-21 |
Licence types: System (1).
Licensed under: ACCELSTIM.
North American profile: Canada only. IGEA S.p.A. holds a Canadian licence but was not found in the U.S. register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
107/MDR | supplemented | 2028-05-02 |