Sixtem Life Srl
IT-MF-000022977 · Italy · Prato (PO)
Sixtem Life Srl is registered in the European database on medical devices as a manufacturer, with 18 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 18 |
|---|
Among these devices, 13 are declared 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 register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 18 |
| 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 |
|---|---|---|
55191 | issued | 2027-12-22 |