Identity
- Trade Name
- AGX FDA UDI
- Generic Name
- Air-conduction hearing aid, in-the-ear FDA UDI
- Device Name
- Audigy AGXWU-IP (Clay brown S-220 ) Left FDA UDI
- Model / Reference
- AGX U-IP FDA UDI
- Description
- Audigy AGXWU-IP (Clay brown S-220 ) Left FDA UDI
Identifiers
- Catalog Number
- 8 315 0303 810 FDA UDI
- Primary DI / UDI-DI
- 05706069749953 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
Agx 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 3190fd87-5e5f-43b0-879c-65a53526e7e0 35 fields · synced Jun 8, 2026