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Bernafon

FDA UDI

Class II (US FDA UDI)

by Bernafon, Inc.

Identity

Trade Name
Bernafon FDA UDI
Generic Name
Hearing aid neck induction loop, wireless input FDA UDI
Device Name
SOUNDGATE 2.0, BERNAFON FDA UDI
Model / Reference
131231 FDA UDI
Description
SOUNDGATE 2.0, BERNAFON FDA UDI

Identifiers

Primary DI / UDI-DI
05711584050354 FDA UDI
FDA Product Code
OSM FDA UDI
GMDN Term
Hearing aid neck induction loop, wireless input FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
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

No

FDA UDI

Over-the-Counter

Yes

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

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Hearing aid neck induction loop, wireless input

Bernafon by Bernafon, Inc. — Class II — 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
Bernafon, Inc.

Sources (1)

  • FDA UDI b7913749-4d48-4e98-ab0d-880f0ff9b0ed 35 fields · synced Jun 6, 2026