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Phonak

FDA UDI

Class I (US FDA UDI)

by Phonak, Inc.

Identity

Trade Name
Phonak FDA UDI
Generic Name
Hearing aid neck induction loop, wireless input FDA UDI
Device Name
Roger MyLink 1.1 (03) (light sterling) FDA UDI
Model / Reference
052-3220-D03M3 FDA UDI
Description
Roger MyLink 1.1 (03) (light sterling) FDA UDI

Identifiers

Catalog Number
052-3220-D03M3 FDA UDI
Primary DI / UDI-DI
07612904275359 FDA UDI
FDA Product Code
ESD FDA UDI
GMDN Term
Hearing aid neck induction loop, wireless input 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 neck induction loop, wireless input

Phonak by Phonak, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hearing aid neck induction loop, wireless input.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Phonak, Inc.

Sources (1)

  • FDA UDI b7b26be8-6083-4e37-86b9-e72ee6f522eb 35 fields · synced May 30, 2026