ENABLE INNOVATIONS SRL
IT-MF-000026066 · Italy · CARPI (MO)
ENABLE INNOVATIONS SRL is registered in the European database on medical devices as a manufacturer, with 192 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 180 |
|---|---|
| Class IIa | 12 |
Most frequent device types declared: Gocce oculari 0,4% HA, Gocce oculari 0,4% HA Plus, Gocce oculari EC+HA, Gocce oculari Innodrops BB, Gocce oculari Innodrops F1a.
Among these devices, 191 are declared sterile.
Devices declared under this manufacturer
- Aactive HA PF 0,4% (GOHAP-003)
- Afomill allergy (GOF1aP-011)
- Aquaeye (GOF1bM-002)
- CF-Eye mono (GOBBM-016)
- DiVial Plus (GOF1bM-004)
- Divial X (GOXM-002)
- EUPIN AEROSOL (S3-014)
- FourHyal (GOHAP-001)
- Innodrops F1a (GOF1aM-001)
- Innodrops LIPO (GOLIPOM-001)
- Perflo drops Gocce oculari (GOF1bM-011)
- Reflex Gocce oculari (GOEC-002)
Showing 12 of 192 declared devices.
Catalogue references include 050262, 050360, 050483, 050508, 050574, 050587.
European nomenclature codes declared: Q0299, Q030199, Q030103.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 192 |
| 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 | 192 |
|---|---|
| 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. ENABLE INNOVATIONS SRL was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
0425-MDR-030179-00 | issued | 2031-03-22 |
0425-MDR-030120-00 | issued | 2030-02-02 |
0425-MDR-030119-01 | supplemented | 2030-02-02 |
0425-MDR-030020-01 | supplemented | 2028-02-26 |