Identity
- Trade Name
- Sony FDA UDI
- Generic Name
- Audiometric/hearing device software FDA UDI
- Device Name
- Sony | Hearing Control App FDA UDI
- Model / Reference
- Sony | Hearing Control FDA UDI
- Description
- Sony | Hearing Control App FDA UDI
Identifiers
- Catalog Number
- 21022296 FDA UDI
- Primary DI / UDI-DI
- 05714880189308 FDA UDI
- FDA Product Code
- QDD FDA UDI
- GMDN Term
- Audiometric/hearing device software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3325 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
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
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 device software
Sony by WS Audiology USA, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- WS Audiology USA, Inc.
Sources (1)
- FDA UDI 88c20af4-6865-46cf-b038-91a122026072 35 fields · synced May 30, 2026