OTOPro By Auditdata

GUDID 05711781001722

Auditdata A/S

Hearing aid tester, electrical
Primary Device ID05711781001722
NIH Device Record Key230a01b9-1305-40e4-bf83-b16ad6e7d629
Commercial Distribution StatusIn Commercial Distribution
Brand NameOTOPro By Auditdata
Version Model NumberOTOPro
Company DUNS310385849
Company NameAuditdata A/S
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105711781001722 [Primary]

FDA Product Code

ETWCalibrator, Hearing Aid / Earphone And Analysis Systems

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-03-05
Device Publish Date2016-08-24

Devices Manufactured by Auditdata A/S

05711781004204 - Measure by Otometrics2025-11-24 2000-1 Fitting Unit Audiometer
05711781004211 - Measure by Otometrics2025-11-24 2000-1 Fitting Unit Audiometer
05711781004228 - Measure by Otometrics2025-11-24 2000-1 Fitting Unit Audiometer
05711781004235 - Measure by Otometrics2025-11-24 2000-1 Fitting Unit Audiometer
05711781004242 - Measure by Otometrics2025-11-24 2000-1 Fitting Unit Audiometer
05711781004259 - Measure by Otometrics2025-11-24 2000-1 Fitting Unit Audiometer
05711781004266 - Measure by Otometrics2025-11-24 2000-1 Fitting Unit Audiometer
05711781004280 - Measure by Otometrics2025-11-24 2000-1 Fitting Unit Audiometer

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