Identity
- Trade Name
- Unity 4 FDA UDI
- Generic Name
- Audiometric/hearing aid tester FDA UDI
- Device Name
- 2000-1 Fitting Unit Audiometer FDA UDI
- Model / Reference
- Unity 4 INSITU Package FDA UDI
- Description
- 2000-1 Fitting Unit Audiometer FDA UDI
Identifiers
- Catalog Number
- 21031181 FDA UDI
- Primary DI / UDI-DI
- 00571178100316 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
- Not 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Unity 4 by Auditdata A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 14cb71b7-49da-4066-a04e-94a56eeae461 35 fields · synced May 30, 2026