Unity 3 21044734

GUDID 05711781004006

U3HIT Package AD-version US

Auditdata A/S

Hearing aid tester, electrical

• Primary Device ID: 05711781004006
• NIH Device Record Key: 34aa060c-a2ed-498e-aec2-be60260a94d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Unity 3
• Version Model Number: Unity 3 HIT UNIT US package
• Catalog Number: 21044734
• 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	05711781004006 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-29
• Device Publish Date: 2024-10-21

Devices Manufactured by Auditdata A/S

• 05711781004204 - Measure by Otometrics: 2025-11-24 2000-1 Fitting Unit Audiometer
• 05711781004211 - Measure by Otometrics: 2025-11-24 2000-1 Fitting Unit Audiometer
• 05711781004228 - Measure by Otometrics: 2025-11-24 2000-1 Fitting Unit Audiometer
• 05711781004235 - Measure by Otometrics: 2025-11-24 2000-1 Fitting Unit Audiometer
• 05711781004242 - Measure by Otometrics: 2025-11-24 2000-1 Fitting Unit Audiometer
• 05711781004259 - Measure by Otometrics: 2025-11-24 2000-1 Fitting Unit Audiometer
• 05711781004266 - Measure by Otometrics: 2025-11-24 2000-1 Fitting Unit Audiometer
• 05711781004280 - Measure by Otometrics: 2025-11-24 2000-1 Fitting Unit Audiometer