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 |
Among these devices, 38 are declared active, 18 with a measuring function.
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 | 38 |
| Country of registration | Netherlands |
⚠️ 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 |
|---|---|---|
SCAR-15.2.1.1 | amended | 2030-10-01 |
2245855CE01 | issued | 2025-10-01 |