Mastelli S.r.l.
IT-MF-000023613 · Italy · Bussana
Mastelli S.r.l. is registered in the European database on medical devices as a manufacturer, with 28 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class I | 28 |
|---|
Most frequent device types declared: RDM60BLS20XS, RDM11BLA20XS, RDM62BLS20XS.
Among these devices, 26 are declared sterile, 22 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 | 28 |
| 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.26/6122 | issued | 2030-07-10 |
EPT 0477.MDR.26/6121 | issued | 2031-03-29 |
EPT 0477.MDR.26/6120 | issued | 2030-07-10 |
EPT 0477.MDR.26/6119 | issued | 2031-03-29 |
CVD006326 | issued | 2031-06-25 |
CSQ003726 | issued | 2031-06-25 |