Identity
- Trade Name
- Widex FDA UDI
- Generic Name
- Hearing aid enhanced audio device, telecommunication/multimedia FDA UDI
- Device Name
- Widex ToneLink App Android FDA UDI
- Model / Reference
- ToneLink app FDA UDI
- Description
- Widex ToneLink App Android FDA UDI
Identifiers
- Catalog Number
- 5 300 0017 001 FDA UDI
- Primary DI / UDI-DI
- 05706069702965 FDA UDI
- FDA Product Code
- ESD FDA UDI
- GMDN Term
- Hearing aid enhanced audio device, telecommunication/multimedia FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.3300 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: Hearing aid enhanced audio device, telecommunication/multimedia
Widex by Widex A/S — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hearing aid enhanced audio device, telecommunication/multimedia.
- STARKEY HEARING TECHNOLOGIES — Starkey Laboratories Inc. · Class II
- GN Hearing — Gn Hearing A/S · Class II
- AMPLIFON — Starkey Laboratories Inc. · Class II
- iCube II — Sonova AG · Class II
- UNITRON — Unitron Hearing Division · Class II
- Sonic — Sonic Innovations, Inc. · Class II
- STARKEY HEARING TECHNOLOGIES — Starkey Laboratories Inc. · Class II
- Hearing Help Express — INTRICON CORPORATION · 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 I | Pending data |
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Manufacturer
- Manufacturer
- Widex A/S
Sources (1)
- FDA UDI e7314efc-c6cc-449e-a454-e372f10fa876 35 fields · synced May 30, 2026