Identity
- Trade Name
- Siemens FDA UDI
- Generic Name
- Audiometric/hearing aid tester FDA UDI
- Device Name
- Siemens UNITY 2 AUDIOMETRY KEYBOARD PACKAGE FDA UDI
- Model / Reference
- UNITY 2 AUDIOMETRY KEYBOARD PACKAGE FDA UDI
- Description
- Siemens UNITY 2 AUDIOMETRY KEYBOARD PACKAGE FDA UDI
Identifiers
- Catalog Number
- 10418927 FDA UDI
- Primary DI / UDI-DI
- 04046355373068 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
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Siemens by WS Audiology USA, Inc. — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- WS Audiology USA, Inc.
Sources (1)
- FDA UDI 844eeb06-41c3-4c83-adfe-1e3e51b70530 36 fields · synced Jun 7, 2026