Identity
- Trade Name
- Earlens Processor & Light Tip FDA UDI
- Generic Name
- Tympanic membrane contact hearing aid ear tip transmitter FDA UDI
- Device Name
- Kit containing 1 Processor and 1 LIght Tip that are connected together Processor comes in different colors: CH - Champagne, SI - Sliver, BL - Black, BE - Beige, BR - Brown LT comes in L - Left, R - Right FDA UDI
- Model / Reference
- PLEL1X FDA UDI
- Description
- Kit containing 1 Processor and 1 LIght Tip that are connected together Processor comes in different colors: CH - Champagne, SI - Sliver, BL - Black, BE - Beige, BR - Brown LT comes in L - Left, R - Right FDA UDI
Identifiers
- Catalog Number
- PLEL1X FDA UDI
- Primary DI / UDI-DI
- 00850013007073 FDA UDI
- FDA Product Code
- PLK FDA UDI
- GMDN Term
- Tympanic membrane contact hearing aid ear tip transmitter 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
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
Earlens Processor & Light Tip 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 |
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Manufacturer
- Manufacturer
- Earlens Corporation
Sources (1)
- FDA UDI e2ca3a0c-8f24-488d-b8b0-171499ccb3a1 36 fields · synced May 30, 2026