Mikai s.p.a.
IT-MF-000030732 · Italy · Genova
Mikai s.p.a. is registered in the European database on medical devices as a manufacturer, with 2 012 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 1 272 |
|---|---|
| Class IIa | 740 |
Most frequent device types declared: Vite BSS, Vite, Arco e anello alluminio, Barra, Accessorio.
Among these devices, 2 010 are declared sterile, 1 272 implantable.
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 register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 2 012 |
| Country of registration | Italy |
⚠️ 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.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
ITH 1343576 1 | issued | 2030-01-23 |