Identity
- Trade Name
- GN Hearing FDA UDI
- Generic Name
- Audiometric/hearing device software FDA UDI
- Device Name
- SW,FSW AUDIGY 3.0 FDA UDI
- Model / Reference
- 23116800 FDA UDI
- Description
- SW,FSW AUDIGY 3.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05708296327225 FDA UDI
- FDA Product Code
- OSM FDA UDI
- GMDN Term
- Audiometric/hearing device software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3305 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Audiometric/hearing device software
GN Hearing by Gn Hearing A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Sonova Brand — Sonova AG · 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
- Gn Hearing A/S
Sources (1)
- FDA UDI 1f3b7152-a80d-4e9e-bf9c-43325cde53b4 34 fields · synced Jun 1, 2026