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Coselgi

FDA UDI

Class II (US FDA UDI)

by Widex A/S

Identity

Trade Name
Coselgi FDA UDI
Generic Name
Air-conduction hearing aid, in-the-ear FDA UDI
Device Name
Coselgi Melodia 3 CMe3-ITE (Dark brown ) Telecoil FDA UDI
Model / Reference
CMe3-ITE FDA UDI
Description
Coselgi Melodia 3 CMe3-ITE (Dark brown ) Telecoil FDA UDI

Identifiers

Catalog Number
8 325 0300 107 FDA UDI
Primary DI / UDI-DI
05706069550474 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

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

No

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 Conditional FDA UDI

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

Coselgi 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Widex A/S

Sources (1)

  • FDA UDI 61bfdb6d-79f9-4a10-adcb-1d16691be67c 35 fields · synced Jun 8, 2026