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Phonak Brand

FDA UDI

Class I (US FDA UDI)

by Sonova AG

Identity

Trade Name
Phonak Brand FDA UDI
Generic Name
Hearing aid enhanced audio device, teaching-environment FDA UDI
Device Name
Roger X without 02 Roger Receiver FDA UDI
Model / Reference
052-3489-X02P5 FDA UDI
Description
Roger X without 02 Roger Receiver FDA UDI

Identifiers

Catalog Number
052-3489-X02P5 FDA UDI
Primary DI / UDI-DI
07613389386714 FDA UDI
FDA Product Code
ESD FDA UDI
GMDN Term
Hearing aid enhanced audio device, teaching-environment FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.3300 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

No

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

Yes

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: Hearing aid enhanced audio device, teaching-environment

Phonak Brand by Sonova AG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hearing aid enhanced audio device, teaching-environment.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sonova AG

Sources (1)

  • FDA UDI d7c2bff3-d2e7-40ba-8f9e-94201ebbc158 35 fields · synced May 30, 2026