Identity
- Trade Name
- NUEAR FDA UDI
- Generic Name
- Audiometric/hearing device software FDA UDI
- Model / Reference
- INSPIRE X FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00842318117199 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Audiometric/hearing device software
Nuear by Starkey Laboratories Inc. — 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
- Nucleus — Cochlear · Class III
- 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
- Starkey Laboratories Inc.
Sources (1)
- FDA UDI a7ef60b8-c987-4c99-9104-dda567a253b0 33 fields · synced Jun 9, 2026