FDA.reportPublic FDA data

Coselgi

Primary DI
05706069475265
Brand
Coselgi
Company
Widex A/S
Model
CMe15-CIC
Catalog number
8 286 0500 025
Device description
Coselgi Melodia 15 CMe15-CIC (Light beige ) Right, RC coil
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional

Contact Domains#

Product Codes#

Code, Name table
CodeName
OSMHearing Aid, Air Conduction With Wireless Technology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OSMHearing Aid, Air-Conduction With Wireless Technology, PrescriptionEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN100025000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN100025000WIDEXLINK IN CLEAR SERIES HEARING AIDSOffice Research IN Clinical Amplifiction2011-03-31OSM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05706069475265PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05706069475265057060694752655706069475265

GMDN Terms#

Term, Definition table
TermDefinition
Canal air-conduction hearing aidA battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It typically consists of a miniature microphone, amplifier, and speaker (receiver) in a case that fits the ear canal [in-the-canal (ITC)] or in a case nearly hidden in the ear canal [completely-in-the-canal (CIC)]. The microphone receives sound waves and converts them into electrical signals which are increased by the amplifier and sent as sound waves, by the speaker, to the eardrum. It is used for mild to moderately-severe hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4544355600widex@widex.com

Regulatory Flags#

DUNS number
309843613
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05714880292077WidexALLURE ARRD2 440210488562026-05-22
05714880292084WidexALLURE ARRD2 440210488552026-05-22
05714880292091WidexALLURE ARRD2 440210488542026-05-22
05714880292107WidexALLURE ARRD2 440210488532026-05-22
05714880292114WidexALLURE ARRD2 440210488522026-05-22
05714880292121WidexALLURE ARRD2 440210488512026-05-22
05714880292138WidexALLURE ARRD2 440210488502026-05-22
05714880292145WidexALLURE ARRD2 440210488492026-05-22
05714880292152WidexALLURE ARRD2 440210488482026-05-22
05714880292169WidexALLURE ARRD2 440210488472026-05-22
05714880292176WidexALLURE ARRD2 330210488462026-05-22
05714880292183WidexALLURE ARRD2 330210488452026-05-22
05714880292190WidexALLURE ARRD2 330210488442026-05-22
05714880292206WidexALLURE ARRD2 330210488432026-05-22
05714880292213WidexALLURE ARRD2 330210488422026-05-22
05714880292220WidexALLURE ARRD2 330210488412026-05-22
05714880292237WidexALLURE ARRD2 330210488402026-05-22
05714880292244WidexALLURE ARRD2 330210488392026-05-22
05714880292251WidexALLURE ARRD2 330210488382026-05-22
05714880292268WidexALLURE ARRD2 330210488372026-05-22

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Primary DI, Brand, Company table
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