Identity
- Trade Name
- Oticon FDA UDI
- Generic Name
- Audiometric/hearing device software FDA UDI
- Device Name
- AUDIGYFIT 2 2019.1 AGX HEARING FDA UDI
- Model / Reference
- 196708 FDA UDI
- Description
- AUDIGYFIT 2 2019.1 AGX HEARING FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05707131345837 FDA UDI
- FDA Product Code
- KLW FDA UDIOSM FDA UDI
- GMDN Term
- Audiometric/hearing device software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3400 FDA UDI874.3305 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
Yes
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
No
FDA UDI
MR Unsafe FDA UDI
Category: Audiometric/hearing device software
Oticon by Oticon A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Audiometric/hearing device software.
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- Widex — Widex A/S · Class I
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- hearX — INTRICON CORPORATION · Class II
- Sonova Brand — Sonova AG · Class II
- 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
- Oticon A/S
Sources (1)
- FDA UDI d9754f62-00cb-4f1e-b658-77c739f48028 35 fields · synced Jun 6, 2026