APrevent Biotech GmbH
AT-MF-000001435 · Austria · Vienna
APrevent Biotech GmbH is registered in the European database on medical devices as a manufacturer, with 25 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 17 |
|---|---|
| Class IIb | 8 |
Most frequent device types declared: APT100.
Among these devices, 8 are declared sterile, 8 implantable, 17 reusable.
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 | 25 |
| Country of registration | Austria |
⚠️ 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 |
|---|---|---|
1000305808 | supplemented | 2030-03-26 |
1000305807 | issued | 2031-03-29 |