FDA.reportPublic FDA data

Widex

Primary DI
05714880292145
Brand
Widex
Company
Widex A/S
Model
ALLURE ARRD2 440
Catalog number
21048849
Device description
HA ALLURE ARRD2 440 HNBL
Published
2026-05-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05714880292145PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05714880292145057148802921455714880292145

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid, receiver-in-canalA battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It consists of a microphone and an amplifier in a case behind-the-ear (BTE) connected, via a wire, to a receiver (speaker) in the ear canal [receiver-in-canal (RIC)]. 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. The device is used for mild to profound hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors.

Contacts#

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

Regulatory Flags#

DUNS number
309843613
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
05714880292275WidexALLURE ARRD2 220210488362026-05-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613389840599Moxi S9-RXSonova AGOSM2026-07-26
07613389840605Moxi S9-RXSonova AGOSM2026-07-26
07613389842012Moxi S7-RXSonova AGOSM2026-07-26
07613389842029Moxi S7-RXSonova AGOSM2026-07-26
07613389842036Moxi S7-RXSonova AGOSM2026-07-26
07613389842043Moxi S7-RXSonova AGOSM2026-07-26
07613389842050Moxi S7-RXSonova AGOSM2026-07-26
07613389842067Moxi S7-RXSonova AGOSM2026-07-26
07613389842074Moxi S9-RXSonova AGOSM2026-07-26
07613389842081Moxi S9-RXSonova AGOSM2026-07-26
07613389842098Moxi S9-RXSonova AGOSM2026-07-26
07613389842104Moxi S9-RXSonova AGOSM2026-07-26
07613389842111Moxi S-RX FLEX:TRIALSonova AGOSM2026-07-26
07613389843682Relate5.0 Platinum RIC RXSonova AGOSM2026-07-26
07613389843699Relate5.0 RIC RX DEMOSonova AGOSM2026-07-26
07613389844627Relate5.0 Gold RIC RXSonova AGOSM2026-07-26
07613389844634Relate5.0 Gold RIC RXSonova AGOSM2026-07-26
07613389844641Relate5.0 Gold RIC RXSonova AGOSM2026-07-26
07613389844658Relate5.0 Platinum RIC RXSonova AGOSM2026-07-26
07613389844665Relate5.0 Platinum RIC RXSonova AGOSM2026-07-26
07613389844955Unitron ChargerGo RIC S-RXSonova AGOSM2026-07-26
07613389844962Easy Line ChargerGo RIC S-RXSonova AGOSM2026-07-26
07613389844979Unitron ChargerGo RIC S-RXSonova AGOSM2026-07-26
07613389844986Unitron ChargerGo RIC S-RXSonova AGOSM2026-07-26
07613389844993Easy Line ChargerGo RIC S-RXSonova AGOSM2026-07-26
07613389845006Easy Line ChargerGo RIC S-RXSonova AGOSM2026-07-26
07613389867022Unitron TrueFit 5.10Sonova AGOSM2026-07-26
07613389867039Aura:fit AudioNova 5.10Sonova AGOSM2026-07-26
07613389867046Aura:fit 5.10Sonova AGOSM2026-07-26
07613389867053HANSATON scout 5.10Sonova AGOSM2026-07-26