Labomar S.p.A.
IT-MF-000007965 · Italy · Istrana
Labomar S.p.A. is registered in the European database on medical devices as a manufacturer, with 274 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 238 |
|---|---|
| Class IIb | 34 |
| Class I | 2 |
Among these devices, 2 are declared sterile.
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 | 274 |
| 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 |
|---|---|---|
EPT 0477.MDR.26/6216 | issued | 2028-06-14 |
CSQ0026240724 | supplemented | 2029-10-27 |