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Primus Fitting Unit +
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 90.3013Model 2000-1 Fitting Unit - Unity 4, Measure, 2000 Primus Pro, Ice, PFU+
Identity
- Trade Name
- Primus Fitting Unit + EUDAMEDPrimus By Auditdata FDA UDI
- Generic Name
- Audiometric/hearing aid tester FDA UDI
- Device Name
- 2000 Fitting Unit, Primus Ice, 2000-1 FU EUDAMED
- Model / Reference
- 2000-1 Fitting Unit - Unity 4, Measure, 2000 Primus Pro, Ice, PFU+ EUDAMED90.3013 EUDAMED2000 Primus Fitting Unit + FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05711781001685 EUDAMEDFDA UDI
- Basic UDI-DI
- 05711781DHF2000ZC EUDAMED
- Direct Marketing DI
- 05711781001685 EUDAMED
- FDA Product Code
- EWO FDA UDI
- EMDN Code
- Z121401 AUDIOMETERS EUDAMED
- GMDN Term
- Audiometric/hearing aid tester FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.1050 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Primus Fitting Unit + by Auditdata A/S — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 05711781DHF2000ZC | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Auditdata A/S
- EUDAMED SRN
- DK-MF-000011415
Sources (2)
- EUDAMED 20fac91a-112c-407a-8b57-8eb2dc60695b 61 fields · synced Jul 23, 2026
- FDA UDI 6472d374-0d17-446d-9564-c5cbb95c834d 32 fields · synced May 30, 2026