Praesidia S.r.l.
IT-MF-000010975 · Italy · Bologna
Praesidia S.r.l. is registered in the European database on medical devices as a manufacturer, with 52 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 22 |
|---|---|
| Class IIa | 30 |
Most frequent device types declared: MaskerOne.
Among these devices, 22 are declared sterile, 22 implantable.
Devices declared under this manufacturer
- EcoTherm
- EndoTracheal SecureFoam
- FLEXIGRIP
- FluidBuster
- Masker
- MaskerOne
- NasoGastric SecureFoam
- OptiMask
- Praesidia Infusion Bag
- VacuStat
Showing 12 of 52 declared devices.
Catalogue references include ET0012, FB14100, FB14150, FG0275, FG0275-1, FG0325-1.
European nomenclature codes declared: H02010202, T0210, T020103, Z12011285, A0303, T0399.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 52 |
| 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 | 52 |
|---|---|
| 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. Praesidia S.r.l. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
MDR 00005-A | issued | 2030-12-03 |