3000 Real Ear

Primary DI
05711781004136
Brand
3000 Real Ear
Company
Auditdata A/S
Model
IN1 Insert Earphone
Catalog number
100.067
Device description
IN1 Insert Earphone (2000-1)
Published
2026-01-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EWOAudiometer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EWOAudiometerEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05711781004136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05711781004136057117810041365711781004136

GMDN Terms#

Term, Definition table
TermDefinition
Earphone, insertAn electroacoustic device intended to be worn in the ear to transmit sound to the ear from an external device for improved hearing or private listening. It is designed to fit either in the outer ear or is attached directly to a connecting element such as an earmould inserted in the ear canal.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
310385849
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
057117810041053000 Real EarCA1 Audiometric Headphone100.0642026-01-23
057117810041433000 Real EarBC1 Bone Conductor100.0602026-01-23
057117810041503000 Real EarCA1 HF Audiometric Headphone100.0652026-01-23
057117810041673000 Real EarSA1 HBA Headphone100.0632026-01-23
057117810041743000 Real EarSA1 RE-7 Headphone100.0682026-01-23
05711781004204Measure by OtometricsAUD Base Package100.4212025-11-14
05711781004211Measure by OtometricsAUD-HF & REM & Speech Mapping Package100.4222025-11-14
05711781004228Measure by OtometricsAUD-HF & Wireless REM & Speech Mapping Package100.4232025-11-14
05711781004235Measure by OtometricsAUD & REM & Speech Mapping Package100.4242025-11-14
05711781004242Measure by OtometricsAUD & Wireless REM & Speech Mapping Package100.4252025-11-14
05711781004259Measure by OtometricsUS/CA AUD & REM & Speech Mapping (ANSI) Package100.4262025-11-14
05711781004266Measure by OtometricsUS/CA AUD & Wireless REM & Speech Mapping (ANSI) P100.4272025-11-14
05711781004280Measure by OtometricsUS/CA AUD Base (ANSI) Package100.4282025-11-14
05711781004297Measure by Otometrics - HITHIT Pro Package100.4502025-11-14
05711781004372Measure by Otometrics - HITUS/CA AUD HIT Pro Package100.4512025-11-14
00571178100316Unity 4Unity 4 INSITU Package210311812024-08-21
05711781004006Unity 3Unity 3 HIT UNIT US package 210447342024-10-21
05711781002743MeasureMeasure Software (USB stick) 100.115 2024-09-17
05711781003818Unity 4 / MeasureUNITY 4 PROBE MIC US PACKAGE210311792024-09-17
05711781002729Unity 4 / MeasureTalk Back Client Microphone (2000-1)100.1132024-08-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05745000311064OscillaOscilla A/SEWO2026-05-29
05745000311095OscillaOscilla A/SEWO2026-05-29
05745000311156OscillaOscilla A/SEWO2026-05-29
05745000311163OscillaOscilla A/SEWO2026-05-29
05745000311187OscillaOscilla A/SEWO2026-05-29
05745000311200OscillaOscilla A/SEWO2026-05-29
00810046707180Grason-StadlerDiagnostic Group LLCEWO2026-04-06
057117810041053000 Real EarAuditdata A/SEWO2026-01-23
057117810041433000 Real EarAuditdata A/SEWO2026-01-23
057117810041503000 Real EarAuditdata A/SEWO2026-01-23
057117810041673000 Real EarAuditdata A/SEWO2026-01-23
057117810041743000 Real EarAuditdata A/SEWO2026-01-23
B43056000011110GoCheckGobiquity, Inc.EWO2026-01-09
B43056000011100GoCheckGobiquity, Inc.EWO2025-12-02
05060753520090Tympa Otoscope SystemTYMPA HEALTH TECHNOLOGIES LIMITEDEWO2025-11-19
B43071000030GoCheck MultiScreenerGobiquity, Inc.EWO2025-11-19
05711781004204Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004211Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004228Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004235Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004242Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004259Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004266Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004280Measure by OtometricsAuditdata A/SEWO2025-11-14
05711117230833Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
05711117230840Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
05711117230857Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
05711117230864Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
05711117245097Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
05711117245103Sanibel Supply A/SInteracoustics A/SEWO2025-08-07