Aidence B.V.
NL-MF-000000534 · Netherlands · Rotterdam
Aidence B.V. is registered in the European database on medical devices as a manufacturer, with 38 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 20 |
|---|---|
| Class IIb | 18 |
Most frequent device types declared: 1, 3.
Among these devices, 38 are declared active, 18 with a measuring function.
Devices declared under this manufacturer
- Veye Clinic
- Veye Engine
- Veye Lung Nodules
Showing 12 of 38 declared devices.
Catalogue references include 1, 3.
European nomenclature codes declared: Z11069082, Z11069092.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 38 |
| Country of registration | Netherlands |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | AIDENCE B.V. |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 1 |
| First licensed | 2023-03-23 |
Licence types: Single Device (1).
Licensed under: VEYE LUNG NODULES.
North American profile: Canada only. Aidence B.V. holds a Canadian licence but was not found in the U.S. register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
SCAR-15.2.1.1 | amended | 2030-10-01 |
2245855CE01 | issued | 2025-10-01 |