OTOPro By Auditdata

GUDID 05711781001722

Auditdata A/S

Hearing aid tester, electrical

• Primary Device ID: 05711781001722
• NIH Device Record Key: 230a01b9-1305-40e4-bf83-b16ad6e7d629
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OTOPro By Auditdata
• Version Model Number: OTOPro
• Company DUNS: 310385849
• Company Name: Auditdata A/S
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05711781001722 [Primary]

FDA Product Code

• ETW: Calibrator, Hearing Aid / Earphone And Analysis Systems

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-03-05
• Device Publish Date: 2016-08-24

Devices Manufactured by Auditdata A/S

• 05711781004006 - Unity 3: 2024-10-29 U3HIT Package AD-version US
• 05711781002743 - Measure: 2024-09-25 2000-1 Fitting Unit Audiometer SW
• 05711781003818 - Unity 4 / Measure: 2024-09-25
• 00571178100316 - Unity 4: 2024-08-29 2000-1 Fitting Unit Audiometer
• 05711781002729 - Unity 4 / Measure: 2024-08-29 2000-1 Fitting Unit Audiometer
• 05711781002736 - Unity 4 / Measure: 2024-08-29 2000-1 Fitting Unit Audiometer
• 05711781002750 - Unity 4: 2024-08-29 2000-1 Fitting Unit Audiometer
• 05711781002774 - Unity 4 / Measure: 2024-08-29 2000-1 Fitting Unit Audiometer