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Denmark·DK-MF-000011415
Last updated September 17, 2026
Information
- Country
- Denmark
- Address
- 10B, Wildersgade, Copenhagen, Denmark
- Website
- www.auditdata.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Denys Lebedev
- EUDAMED SRN
- DK-MF-000011415
- FDA FEI Number
- 3008386587
- DUNS Number
- 310385849
Catalogue (36)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Amplitude By Auditdata | Amplitude T4 | FDA UDI | Class II | Active |
| Unity 4 / Measure | Talk Forward Operator Headset (2000-1) | FDA UDI | Class II | Active |
| Unity 4 | Unity 4 USB Stick | FDA UDI | Class II | Active |
| OTOPro By Auditdata | OTOPro | FDA UDI | Class II | Active |
| Unity 4 / Measure | Talk Back Client Microphone (2000-1) | FDA UDI | Class II | Active |
| OTOSphere By Auditdata | OTOSphere | FDA UDI | Class II | Active |
| Unity 4 / Measure | B71 Bone Conductor (2000-1) | FDA UDI | Class II | Active |
| Primus By Auditdata | 2000 Primus HIT Pro | FDA UDI | Class II | Active |
| Unity 4 / Measure | REM Probe Flex (2000-1) | FDA UDI | Class II | Active |
| Entomed By Auditdata | SA 201 (Spanish) | FDA UDI | Class II | Active |
| Primus By Auditdata | 2000 Primus Fitting Unit Pro | FDA UDI | Class II | Unknown |
| Unity 4 / Measure | UNITY 4 PROBE MIC US PACKAGE | FDA UDI | Class II | Active |
| Unity 4 / Measure | DD45 Headphone w. HBA (2000-1) | FDA UDI | Class II | Active |
| OTOPod By Auditdata | OTOPod M1 | FDA UDI | Class II | Active |
| Unity 4 / Measure | REM/Free Field Speaker (2000-1) | FDA UDI | Class II | Active |
| Entomed By Auditdata | SA 202 (Spanish) | FDA UDI | Class II | Active |
| Primus By Auditdata | 2000 Primus HIT Unit | FDA UDI | Class II | Active |
| Unity 4 | Unity 4 INSITU Package | FDA UDI | Class II | Unknown |
| Unity 4 / Measure | Insert Earphone (2000-1) | FDA UDI | Class II | Active |
| Entomed By Auditdata | SA 204 (Spanish) | FDA UDI | Class II | Active |
| Measure | Measure Software (USB stick) | FDA UDI | Class II | Active |
| OTOPod By Auditdata | OTOPod M2 | FDA UDI | Class II | Active |
| Measure/Unity 4 | 2000-1 Fitting Unit | FDA UDI | Class II | Active |
| Unity 3 | Unity 3 HIT UNIT US package | FDA UDI | Class II | Active |
| Entomed By Auditdata | SA 203 (Spanish) | FDA UDI | Class II | Active |
| Amplitude By Auditdata | Amplitude T3 | FDA UDI | Class II | Active |
| Unity 4, Measure | 100.310 | EUDAMEDFDA UDI | Class IIa | Active |
| Primus Hearing Instrument Test Unit | K113831 | FDA 510(k) | Class II | Active |
| Entomed SA201 | SA201 | EUDAMEDFDA UDI | Class IIa | Active |
| Entomed SA203 | SA203 | EUDAMEDFDA UDI | Class IIa | Active |
| Entomed SA202 | SA202 | EUDAMEDFDA UDI | Class IIa | Active |
| Auditbase | 2003 Auditbase | EUDAMED | Class IIb | Active |
| Entomed SA204 | SA204 | EUDAMEDFDA UDI | Class IIa | Active |
| Primus Ice | 90.3030 | EUDAMEDFDA UDI | Class IIa | Active |
| Primus Fitting Unit + | 90.3013 | EUDAMEDFDA UDI | Class IIa | Active |
| 2000 Primus Fitting Unit Pro | 90.3029 | EUDAMEDFDA UDI | Class IIa | Active |
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