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Audibel

FDA UDI

Class II (US FDA UDI)

by Starkey Laboratories Inc.

Identity

Trade Name
AUDIBEL FDA UDI
Generic Name
Tinnitus masking application software FDA UDI
Model / Reference
INVISIBEL SYN IQ 1200 WRLS IIC FDA UDI

Identifiers

Catalog Number
VN3I FDA UDI
Primary DI / UDI-DI
00842318130303 FDA UDI
FDA Product Code
KLW FDA UDI
OSM FDA UDI
GMDN Term
Tinnitus masking application software 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, 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 01466cc4-f80d-4753-81f6-751b205c2e18 34 fields · synced Jun 9, 2026