Bernafon

FDA UDI

Class II (US FDA UDI)

by Bernafon, Inc.

Identity

Trade Name: Bernafon FDA UDI
Generic Name: Air-conduction hearing aid, in-the-ear FDA UDI
Device Name: ZR9, KIT 10 85 BE ZERENA 9 FDA UDI
Model / Reference: 185894 FDA UDI
Description: ZR9, KIT 10 85 BE ZERENA 9 FDA UDI

Identifiers

Primary DI / UDI-DI: 05711584083352 FDA UDI
510(k) Number: K133308 FDA UDI
FDA Product Code: KLW FDA UDI
GMDN Term: Air-conduction hearing aid, in-the-ear FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 874.3400 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Air-conduction hearing aid, in-the-ear

Bernafon by Bernafon, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Air-conduction hearing aid, in-the-ear.

AUDIBEL — Starkey Laboratories Inc. · Class II
Unitron — Unitron Hearing · Class I
AGX — Widex A/S · Class II
Widex — Widex A/S · Class II
Ceretone — AUDICON CORPORATION · Class I
AUDIGY — Starkey Laboratories Inc. · Class II
Widex — Widex A/S · Class II
GN ReSound — Gn Hearing A/S · Class II

Cleared under the same submission

K133308 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Bernafon, Inc.

Sources (1)

FDA UDI 07db1668-485b-4a12-ba0d-584b4d1b5115 35 fields · synced May 30, 2026