BETATEX SPA
IT-MF-000009955 · Italy · ASSISI
BETATEX SPA is registered in the European database on medical devices as a manufacturer, with 13 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 7 |
|---|---|
| Class I | 3 |
| Class IIb | 3 |
Most frequent device types declared: MTK1058/ISK-19, TECNODRAPE - TELERIA STANDARD CON ANTIBATTERICO, SE0164SEA, SF3064SE_T, TELERIA SPECIALISTICA CON ANTIBATTERICO.
Among these devices, 13 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 | 13 |
| 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 |
|---|---|---|
CVD001823 | issued | 2027-10-23 |
CVD001723 | issued | 2027-10-23 |