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Unity 4, Measure
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 100.310Model 2000-1 Fitting Unit - Unity 4, Measure, 2000 Primus Pro, Ice, PFU+
Identity
- Trade Name
- Unity 4, Measure EUDAMEDUnity 4 / Measure FDA UDI
- Generic Name
- Audiometric/hearing aid tester FDA UDI
- Device Name
- 2000 Fitting Unit, Primus Ice, 2000-1 FU EUDAMED2000-1 Fitting Unit Audiometer FDA UDI
- Model / Reference
- 2000-1 Fitting Unit - Unity 4, Measure, 2000 Primus Pro, Ice, PFU+ EUDAMED100.310 EUDAMEDFitting Unit Package (2000-1) FDA UDI
- Description
- 2000-1 Fitting Unit Audiometer FDA UDI
Identifiers
- Catalog Number
- 100.310 FDA UDI
- Primary DI / UDI-DI
- 05711781002705 EUDAMED05711781003078 FDA UDI
- Basic UDI-DI
- 05711781DHF2000ZC 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Unity 4, Measure 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 fdc7b269-b639-4a1b-bd74-a8cd950e122d 61 fields · synced Jul 14, 2026
- FDA UDI 1e29983f-be75-4d4d-9e40-140fec72ab94 34 fields · synced May 29, 2026