DIFFUPLAST srl
IT-MF-000022506 · Italy · Olgiate Olona (Va)
DIFFUPLAST srl is registered in the European database on medical devices as a manufacturer, with 51 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 51 |
|---|
Among these devices, 51 are declared sterile.
Devices declared under this manufacturer
- ExactaMiX MULTILAYER
- ExactaMix MULTILAYER
- ExactaMix EVA
- ExactaMix MULTILAYER
- ExactaMix SET
- KabiHelp Advance Plus LL
- KabiHelp Uno
- KabiHelp Uno LL
Showing 12 of 51 declared devices.
Catalogue references include E1301OLPF, E1330OLPF, E1340OLPF, E1402OD, E1402OD5, F1305AFCA.
European nomenclature codes declared: A080102, A088099, A080199,A088099.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 51 |
| 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 | 51 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | DIFFUPLAST SRL |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 1 |
| First licensed | 2024-03-27 |
Licence types: Device Family (1).
Licensed under: KABIHELP.
North American profile: Canada only. DIFFUPLAST srl holds a Canadian licence but was not found in the U.S. register.