Measure/Unity 4

GUDID 05711781002675

Auditdata A/S

Audiometric/hearing aid tester

• Primary Device ID: 05711781002675
• NIH Device Record Key: 4123f437-c78e-42cf-8471-7de4d381f1df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Measure/Unity 4
• Version Model Number: 2000-1 Fitting Unit
• 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: true
• 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	05711781002675 [Primary]

FDA Product Code

• EWO: Audiometer

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: 2024-05-06
• Device Publish Date: 2024-04-26

Devices Manufactured by Auditdata A/S

• 05711781004105 - 3000 Real Ear: 2026-02-02 CA1 Audiometric Headphone (2000-1)
• 05711781004136 - 3000 Real Ear: 2026-02-02 IN1 Insert Earphone (2000-1)
• 05711781004143 - 3000 Real Ear: 2026-02-02 BC1 Bone Conductor (2000-1)
• 05711781004150 - 3000 Real Ear: 2026-02-02 CA1 HF Audiometric Headphone (2000-1)
• 05711781004167 - 3000 Real Ear: 2026-02-02 SA1 HBA Headphone (2000-1)
• 05711781004174 - 3000 Real Ear: 2026-02-02 SA1 RE-7 Headphone (2000-1)
• 05711781004204 - Measure by Otometrics: 2025-11-24 2000-1 Fitting Unit Audiometer
• 05711781004211 - Measure by Otometrics: 2025-11-24 2000-1 Fitting Unit Audiometer