Widex

FDA UDI

Class II (US FDA UDI)

by Widex A/S

Identity

Trade Name: Widex FDA UDI
Generic Name: Air-conduction hearing aid, in-the-ear FDA UDI
Device Name: Widex EVOKE E-XP (Clay brown S-110 ) Telecoil, RC coil FDA UDI
Model / Reference: E-XP FDA UDI
Description: Widex EVOKE E-XP (Clay brown S-110 ) Telecoil, RC coil FDA UDI

Identifiers

Catalog Number: 8 405 0100 809 FDA UDI
Primary DI / UDI-DI: 05706069725087 FDA UDI
FDA Product Code: OSM FDA UDI
GMDN Term: Air-conduction hearing aid, in-the-ear 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

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

Widex by Widex A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

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

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Widex A/S

Sources (1)

FDA UDI 1a71e955-a893-4935-8cf3-db61de590f19 36 fields · synced May 31, 2026