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Earlens Processor & Light Tip

FDA UDI

Class II (US FDA UDI)

by Earlens Corporation

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 left Processor & Lght Tip that are connected together and 1 right Processor & Lght Tip that are connected together Processor comes in different colors: CH - Champagne, SI - Sliver, BL - Black, BE - Beige, BR - Brown FDA UDI
Model / Reference
PLEL1LR FDA UDI
Description
Kit containing 1 left Processor & Lght Tip that are connected together and 1 right Processor & Lght Tip that are connected together Processor comes in different colors: CH - Champagne, SI - Sliver, BL - Black, BE - Beige, BR - Brown FDA UDI

Identifiers

Catalog Number
PLEL1LR FDA UDI
Primary DI / UDI-DI
08500130070086 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

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Manufacturer

Manufacturer
Earlens Corporation

Sources (1)

  • FDA UDI 27037f91-65d8-47f1-a6fa-1e10366c3b04 36 fields · synced Jun 1, 2026