FDA.report

Widex

Primary DI
05706069424461
Brand
Widex
Company
Widex A/S
Model
ME-9
Catalog number
8 372 0100 081
Device description
Widex MENU ME-9 BTE (Tan silk ) Telecoil, RC coil
Published
2017-01-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
ESDHearing Aid, Air Conduction

Product Code Classifications

CodeDeviceSpecialtyClass
ESDHearing Aid, Air-Conduction, PrescriptionEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05706069424461PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05706069424461057060694244615706069424461

GMDN Terms

TermDefinition
Behind-the-ear 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 microphone, an amplifier, and a speaker (receiver) contained in a case worn behind-the-ear (BTE). 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 through an earmould that fits inside the outer ear or a tube in the ear canal. 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.

Storage And Handling

TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius50 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius55 Degrees Celsius

Sterilization Methods

Method

Contacts

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
true
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

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05714880266825WidexWPP101210448492025-09-26
05714880208993WidexALLURE ARRD1210290112025-03-06
05714880209624WidexALLURE ARRD1 440210289412025-03-06
05714880189377WidexALLURE ARRD1 440210233412024-10-29
05714880209006WidexALLURE ARRD1210289902024-10-29
05714880209013WidexALLURE ARRD1210289952024-10-29
05714880209020WidexALLURE ARRD1210290072024-10-29
05714880209051WidexALLURE ARRD1210289862024-10-29
05714880209068WidexALLURE ARRD1210289822024-10-29
05714880209075WidexALLURE ARRD1210290152024-10-29
05714880209297WidexALLURE ARRD1210290032024-10-29
05714880209303WidexALLURE ARRD1210289992024-10-29
05714880209310WidexALLURE ARRD1 110210289892024-10-29
05714880209327WidexALLURE ARRD1210289782024-10-29
05714880209334WidexALLURE ARRD1 110210290102024-10-29
05714880209341WidexALLURE ARRD1 110210289942024-10-29
05714880209358WidexALLURE ARRD1 110210290062024-10-29
05714880209365WidexALLURE ARRD1 110210289852024-10-29
05714880209372WidexALLURE ARRD1 110210289812024-10-29
05714880209389WidexALLURE ARRD1 110210290142024-10-29

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
05708296429073GN HearingGn Hearing A/SESD2026-03-05
05708296429080GN HearingGn Hearing A/SESD2026-03-05
05708296429097GN HearingGn Hearing A/SESD2026-03-05
EDET030161medicalprint shell beige 2.0 1000gDETAX GmbHESD2026-02-25
00810068833218Lucid Hearing®HEARING LAB TECHNOLOGY, LLCESD2026-02-13
05708296382927BeltoneGn Hearing A/SESD2026-02-10
05708296382934BeltoneGn Hearing A/SESD2026-02-10
05708296382941BeltoneGn Hearing A/SESD2026-02-10
05708296383061BeltoneGn Hearing A/SESD2026-02-10
05708296383078BeltoneGn Hearing A/SESD2026-02-10
05708296383085BeltoneGn Hearing A/SESD2026-02-10
05708296383207BeltoneGn Hearing A/SESD2026-02-10
05708296383214BeltoneGn Hearing A/SESD2026-02-10
05708296383221BeltoneGn Hearing A/SESD2026-02-10
05708296383344BeltoneGn Hearing A/SESD2026-02-10
05708296383351BeltoneGn Hearing A/SESD2026-02-10
05708296383368BeltoneGn Hearing A/SESD2026-02-10
05708296383481GN ReSoundGn Hearing A/SESD2026-02-10
05708296383498GN ReSoundGn Hearing A/SESD2026-02-10
05708296383504GN ReSoundGn Hearing A/SESD2026-02-10
05708296383627GN ReSoundGn Hearing A/SESD2026-02-10
05708296383634GN ReSoundGn Hearing A/SESD2026-02-10
05708296383641GN ReSoundGn Hearing A/SESD2026-02-10
05708296383764GN ReSoundGn Hearing A/SESD2026-02-10
05708296383771GN ReSoundGn Hearing A/SESD2026-02-10
05708296383788GN ReSoundGn Hearing A/SESD2026-02-10
05708296383900GN ReSoundGn Hearing A/SESD2026-02-10
05708296383917GN ReSoundGn Hearing A/SESD2026-02-10
05708296383924GN ReSoundGn Hearing A/SESD2026-02-10
05708296384044GN HearingGn Hearing A/SESD2026-02-10