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.
Devices declared under this manufacturer
- APrevent® VOIS Instrument
- VOIS-L
- VOIS-L_3.5
- VOIS-M
- VOIS-M_3.5
- VOIS-S
- VOIS-S_3.0
- VOIS-XS
- VOIS-XS_3.0
Showing 12 of 25 declared devices.
Catalogue references include APT104, APT105, APT106, APT115, APV003, APV008.
European nomenclature codes declared: L149099, P0204.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 25 |
| Country of registration | Austria |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 25 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. APrevent Biotech GmbH was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
1000305808 | supplemented | 2030-03-26 |
1000305807 | issued | 2031-03-29 |