EU → US Device Access

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 IIb826
Class IIa123

Most frequent device types declared: TITANIUM CAGE, Kyphoplastic, verthebroplastic devices and accessories, ACC14140405, Vertebroplastica.

Among these devices, 828 are declared sterile, 826 implantable, 121 reusable, 1 active.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED949
Country of registrationItaly
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

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