Santex S.p.A.
IT-MF-000010188 · Italy · MILANO
Santex S.p.A. is registered in the European database on medical devices as a manufacturer, with 592 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 592 |
|---|
Most frequent device types declared: Pannoloni a mutandina con fissaggio classico, Pannoloni mutandina con fissaggio integrato tipo Pants, GARZE LAPAROTOMICHE STERILI, COMPRESSE PIEGATE STERILI, TAMPONI DI GARZA STERILI.
Among these devices, 144 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 | 592 |
| 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 |
|---|---|---|
MDR 00155-A | issued | 2030-06-17 |