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Audigy

FDA UDI

Class I (US FDA UDI)

by Starkey Laboratories Inc.

Identity

Trade Name
AUDIGY FDA UDI
Generic Name
Tinnitus masking application software FDA UDI
Model / Reference
AUDIGY SIGNATURE SERIES 16 IIC NW FDA UDI

Identifiers

Primary DI / UDI-DI
00840388202104 FDA UDI
FDA Product Code
ESD FDA UDI
KLW FDA UDI
GMDN Term
Tinnitus masking application software FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.3300 FDA UDI
874.3400 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

Audigy by Starkey Laboratories Inc. — Class I — 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 86038f52-a3ea-47a9-bb10-0dd04aead55a 33 fields · synced Jun 9, 2026