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: 2000-1 Fitting Unit - Unity 4, Measure, 2000 Primus Pro, Ice, PFU+, 2003 Auditbase, SA 201, SA202, SA203, SA204.
Among these devices, 8 are declared active, 8 with a measuring function.
Devices declared under this manufacturer
- 2000 Primus Fitting Unit Pro
- Auditbase
- Entomed SA201
- Entomed SA202
- Entomed SA203
- Entomed SA204
- Primus Fitting Unit +
- Primus Ice
- Unity 4, Measure
Catalogue references include 100.310, 90.3013, 90.3029, 90.3030, SA201, SA202.
European nomenclature codes declared: Z121401, Z12149092.
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 |
Device-level evidence
| Devices with a numeric GTIN | 9 |
|---|---|
| Found in the U.S. device database | 8 |
| Share | 88.9 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | AUDITDATA A/S |
What it holds in Canada
| Licences on record | 5 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 5 |
| First licensed | 2016-09-08 |
Licence types: System (3), Device Family (2).
Licensed under: 2000 PRIMUS AUDIOMETER UNIT ICE, 2000 PRIMUS FITTING UNIT PRO, SCREENING AUDIOMETERS, 2000 PRIMUS HIT UNIT, 2000-1 FITTING UNIT.
North American profile: Both markets. Auditdata A/S is registered in both the United States and Canada.