Identity
- Trade Name
- Earlens Fidelity Software FDA UDI
- Generic Name
- Audiometric/hearing device software FDA UDI
- Device Name
- Earlens Fitting Software. Lot Number is for manufacturing packaging of software. Version is in Application Identifier (8012). FDA UDI
- Model / Reference
- ELF003 FDA UDI
- Description
- Earlens Fitting Software. Lot Number is for manufacturing packaging of software. Version is in Application Identifier (8012). FDA UDI
Identifiers
- Catalog Number
- ELF003 FDA UDI
- Primary DI / UDI-DI
- 00850013007417 FDA UDI
- 510(k) Number
- K182480 FDA UDI
- FDA Product Code
- PLK FDA UDI
- GMDN Term
- Audiometric/hearing device software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3315 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Audiometric/hearing device software
Earlens Fidelity Software by Earlens Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Audiometric/hearing device software.
- CUSTOM SND SUITE 1.3 SERV RELEASE 1 — Cochlear · Class III
- Boots Hearingcare 2 — Sonova AG · Class II
- Sonova Brand — Sonova AG · Class II
- 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
Cleared under the same submission
K182480 also covers:
- Earlens Contact Hearing Solution, Binaural — EARLENS CORPORATION
- Earlens Contact Hearing Solution, Monaural, Left — EARLENS CORPORATION
- Earlens Contact Hearing Solution, Monaural, Right — EARLENS CORPORATION
- Earlens Ear Tip, Binaural — EARLENS CORPORATION
- Earlens Ear Tip, Left — EARLENS CORPORATION
- Earlens Ear Tip, Right — EARLENS CORPORATION
- Earlens Processor, Black — EARLENS CORPORATION
- Earlens Processor, Champagne — EARLENS CORPORATION
- Earlens Processor, Silver — EARLENS CORPORATION
- Earlens Tympanic Lens, Binaural — EARLENS CORPORATION
- Earlens Tympanic Lens, Left — EARLENS CORPORATION
- Earlens Tympanic Lens, Right — EARLENS CORPORATION
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Earlens Corporation
Sources (1)
- FDA UDI dfa666bb-f33a-42d2-8b0f-4a743f09a435 35 fields · synced May 30, 2026