Tsunami Medical SRL
IT-MF-000007198 · Italy · Modena
Tsunami Medical SRL is registered in the European database on medical devices as a manufacturer, with 949 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 826 |
|---|---|
| Class IIa | 123 |
Most frequent device types declared: ACC14140405, Kyphoplastic, verthebroplastic devices and accessories, TITANIUM CAGE, Vertebroplastica.
Among these devices, 828 are declared sterile, 826 implantable, 121 reusable, 1 active.
Catalogue references include ACC14140400, ACC14140900, ACC14140905, ACP29101008, ACX58181300, TACC14120905.
European nomenclature codes declared: P09070101, L1199, A019013, A018002.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 949 |
| 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 | 949 |
|---|---|
| Found in the U.S. device database | 1 |
| Share | 0.1 % |
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. Tsunami Medical SRL was not found in either the U.S. or the Canadian register.