Auditdata A/S
DK-MF-000011415 · Denmark · Copenhagen
Auditdata A/S is registered in the European database on medical devices as a manufacturer, with 9 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 8 |
|---|---|
| Class IIb | 1 |
Most frequent device types declared: SA 201, SA202, SA203, SA204, 2000-1 Fitting Unit - Unity 4, Measure, 2000 Primus Pro, Ice, PFU+, 2003 Auditbase.
Among these devices, 8 are declared active, 8 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 | Registered with FDA |
|---|---|
| Matched entry | Auditdata A/S (DK) · FDA 3008386587 |
| Devices in EUDAMED | 9 |
| Country of registration | Denmark |