Widex

FDA UDI

Class I (US FDA UDI)

by Widex A/S

Identity

Trade Name: Widex FDA UDI
Generic Name: Air-conduction hearing aid, canal FDA UDI
Device Name: Widex Mind440 M4-CIC/IIC (Light beige S-440 ) Transverse receiver FDA UDI
Model / Reference: M4-CIC FDA UDI
Description: Widex Mind440 M4-CIC/IIC (Light beige S-440 ) Transverse receiver FDA UDI

Identifiers

Catalog Number: 8 076 0300 808 FDA UDI
Primary DI / UDI-DI: 05706069726510 FDA UDI
FDA Product Code: ESD FDA UDI
GMDN Term: Air-conduction hearing aid, canal 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

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, canal

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

Similar devices

Also classified as Air-conduction hearing aid, canal.

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Oticon — Oticon A/S · Class II
GN ReSound — Gn Hearing A/S · Class I
MICROTECH — Starkey Laboratories Inc. · Class II
Bernafon — Bernafon, Inc. · Class II
KIND — Starkey Laboratories Inc. · Class II
NUEAR — Starkey Laboratories 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 I	Pending data

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Manufacturer

Manufacturer: Widex A/S

Sources (1)

FDA UDI 250a82e9-3d36-4d4e-a038-c1acc19575cb 36 fields · synced Jun 8, 2026