Identity
- Trade Name
- Unity 4 / Measure FDA UDI
- Generic Name
- Audiometric/hearing aid tester FDA UDI
- Device Name
- 2000-1 Fitting Unit Audiometer FDA UDI
- Model / Reference
- REM/Free Field Speaker (2000-1) FDA UDI
- Description
- 2000-1 Fitting Unit Audiometer FDA UDI
Identifiers
- Catalog Number
- 100.040 FDA UDI
- Primary DI / UDI-DI
- 05711781002774 FDA UDI
- FDA Product Code
- EWO FDA UDI
- GMDN Term
- Audiometric/hearing aid tester FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.1050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Category: Audiometric/hearing aid tester
Unity 4 / Measure by Auditdata A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Audiometric/hearing aid tester.
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- REAL-EAR — WS Audiology USA, Inc. · Class II
- REAL-EAR — WS Audiology USA, Inc. · Class II
- Audioscan — Etymonic Design Incorporated · Class II
- REAL-EAR — WS Audiology USA, Inc. · Class II
- Etymotic Research — ETYMOTIC RESEARCH, INC. · Class II
- Sanibel Supply A/S — Interacoustics A/S · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Auditdata A/S
Sources (1)
- FDA UDI 0e1cea4f-1f63-475e-9357-addb6a5c6ec0 34 fields · synced May 30, 2026