Esoform S.p.A.
IT-MF-000028984 · Italy · Rovigo
Esoform S.p.A. is registered in the European database on medical devices as a manufacturer, with 76 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 75 |
|---|---|
| Class IIb | 1 |
Among these devices, 1 are declared sterile.
Devices declared under this manufacturer
- VisioSan Lesehilfe 10 Dioptrie +2,0
- VisioSan Lesehilfe 11 Dioptrie +3,0
- VisioSan Lesehilfe 13 Dioptrie +2,0
- VisioSan Lesehilfe 13 Dioptrie +3,5
- VisioSan Lesehilfe 15 Dioptrie +3,0
- VisioSan Lesehilfe 2 Dioptrie +2,0
- VisioSan Lesehilfe 3 Dioptrie +1,0
- VisioSan Lesehilfe 4 Dioptrie +3,5
- VisioSan Lesehilfe 4 Dioptrie +2,5
- VisioSan Lesehilfe 6 Dioptrie +3,5
- VisioSan Lesehilfe 7 Dioptrie +1,5
- VisioSan Lesehilfe 8 Dioptrie +1,5
Showing 12 of 76 declared devices.
Catalogue references include LHE02C1B200, LHE03C1B100, LHE04C1B250, LHE04C1B350, LHE08C1B150, LHE08C1B200.
European nomenclature codes declared: Q0210030102, Q0299.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 76 |
| 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 | 76 |
|---|---|
| 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. Esoform S.p.A. was not found in either the U.S. or the Canadian register.