Identity
- Trade Name
- Earlens ELF USB FDA UDI
- Generic Name
- Audiometric/hearing device software FDA UDI
- Device Name
- Earlens Fitting Software, Wireless Application Identifier (8012) contains the software version Lot Number is the packaging lot number FDA UDI
- Model / Reference
- ELFW01 FDA UDI
- Description
- Earlens Fitting Software, Wireless Application Identifier (8012) contains the software version Lot Number is the packaging lot number FDA UDI
Identifiers
- Catalog Number
- ELFW01 FDA UDI
- Primary DI / UDI-DI
- 08500130070192 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
- Not 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Earlens ELF USB by Earlens Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 8a7516b5-5b28-41dd-8d28-2ea4d5f0d9e1 35 fields · synced Jun 8, 2026