Mondial Srl
IT-MF-000022978 · Italy · Limena
Mondial Srl is registered in the European database on medical devices as a manufacturer, with 75 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 64 |
|---|---|
| Class IIb | 11 |
Most frequent device types declared: FT03, FT04, FT06, FT10, FT17.
Devices declared under this manufacturer
- AXA LUBRI
- AXA Pronto
- AXA WHITE
- Actizyme
- DETERBITE
- DIALMATIK M
- DIALZIMA MED
- DLP 18
- DLP-15
- MULTI MED INSTRUPRO
- MULTI MED NZ
- RINSEOFF OB
Showing 12 of 75 declared devices.
Catalogue references include FM0343, FM0500, FM0612, FM0888, FM0950, FM1245.
European nomenclature codes declared: D0899, D0899,V0799, D0801, D99, V0799, D0901.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 75 |
| 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 | 63 |
|---|---|
| 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. Mondial Srl was not found in either the U.S. or the Canadian register.