Mesa Italia S.r.l.
IT-MF-000029407 · Italy · Travagliato
Mesa Italia S.r.l. is registered in the European database on medical devices as a manufacturer, with 238 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 238 |
|---|
Most frequent device types declared: Alloys for full-cast metal crowns and FPDs - Alloys for metal-ceramic , Alloys for plates of RPDs, Alloys for welding, Magnum Hyperone.
Among these devices, 191 are declared implantable.
Devices declared under this manufacturer
- Magnum Adamanta 2
- Magnum Album
- Magnum Hyerone
- Magnum Hyperone
- Magnum Saldatura A
- Magnum Saldatura B
- Magnum Saldatura Co
- Magnum Solare
- Magnum Splendidum
- Magnum VIP
- Magnum VIP-A
Showing 12 of 238 declared devices.
Catalogue references include 40180033A, 40200006A, 41010120A, 41010412A, 41300054A, 41300055A.
European nomenclature codes declared: Q010601.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | MESA ITALIA S.R.L. (IT) · FDA 3010388903 |
| Devices in EUDAMED | 238 |
| Country of registration | Italy |
Device-level evidence
| Devices with a numeric GTIN | 238 |
|---|---|
| Found in the U.S. device database | 95 |
| Share | 39.9 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | MESA ITALIA S.R.L. |
What it holds in Canada
| Licences on record | 4 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 2 |
| Class 3 devices | 2 |
| First licensed | 2017-05-10 |
Licence types: Device Family (3), Single Device (1).
Licensed under: NICKEL BASED DENTAL ALLOY INTENDED TO BE USED , COBALT BASED DENTAL ALLOY INTENDED TO BE USED , COBALT BASED DENTAL ALLOY FOR CERAMIC, TITANIUM ALLOY FOR CAD/CAM MILLING.
North American profile: Both markets. Mesa Italia S.r.l. is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
0425-MDR-030016-00 | issued | 2028-01-31 |