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Audibel

FDA UDI

Class II (US FDA UDI)

by Starkey Laboratories Inc.

Identity

Trade Name
AUDIBEL FDA UDI
Generic Name
Air-conduction hearing aid, receiver-in-canal FDA UDI
Model / Reference
A4I GOLD WRLS RIC 312 FDA UDI

Identifiers

Catalog Number
64253-2 FDA UDI
Primary DI / UDI-DI
00842318116451 FDA UDI
FDA Product Code
KLW FDA UDI
OSM FDA UDI
GMDN Term
Air-conduction hearing aid, receiver-in-canal FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.3400 FDA UDI
874.3305 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
MRI Safety
MR Unsafe FDA UDI

Category: Air-conduction hearing aid, receiver-in-canalTinnitus masking application software

Audibel by Starkey Laboratories Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tinnitus masking application software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Starkey Laboratories Inc.

Sources (1)

  • FDA UDI 28a2585f-5399-4e36-b171-fa066501a6db 34 fields · synced Jun 9, 2026