Identity
- Trade Name
- Widex FDA UDI
- Generic Name
- Air-conduction hearing aid, in-the-ear FDA UDI
- Device Name
- Widex UNIQUE U-IP (Dark brown ) 330, Left FDA UDI
- Model / Reference
- U-IP FDA UDI
- Description
- Widex UNIQUE U-IP (Dark brown ) 330, Left FDA UDI
Identifiers
- Catalog Number
- 8 315 0330 107 FDA UDI
- Primary DI / UDI-DI
- 05706069655186 FDA UDI
- FDA Product Code
- OSM FDA UDI
- GMDN Term
- Air-conduction hearing aid, in-the-ear 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Air-conduction hearing aid, in-the-ear
Widex by Widex A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Air-conduction hearing aid, in-the-ear.
- Bernafon — Bernafon, Inc. · Class II
- AUDIBEL — Starkey Laboratories Inc. · Class II
- Unitron — Unitron Hearing · Class I
- Ceretone — AUDICON CORPORATION · Class I
- Bernafon — Bernafon, Inc. · Class II
- AUDIGY — Starkey Laboratories Inc. · Class II
- GN ReSound — Gn Hearing A/S · Class II
- Bernafon — Bernafon, Inc. · 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
- Widex A/S
Sources (1)
- FDA UDI bd3b52de-3987-4c5a-b81f-b4197d0ada7b 35 fields · synced May 30, 2026