3000 Real Ear 100.064

GUDID 05711781004105

CA1 Audiometric Headphone (2000-1)

Auditdata A/S

Earphone, circumaural

• Primary Device ID: 05711781004105
• NIH Device Record Key: 368fd314-5c5a-4ff2-ab6f-f82dd3ac3e9b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3000 Real Ear
• Version Model Number: CA1 Audiometric Headphone
• Catalog Number: 100.064
• 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	05711781004105 [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: 2026-02-02
• Device Publish Date: 2026-01-23

On-Brand Devices [3000 Real Ear]

• 05711781004174: SA1 RE-7 Headphone (2000-1)
• 05711781004167: SA1 HBA Headphone (2000-1)
• 05711781004150: CA1 HF Audiometric Headphone (2000-1)
• 05711781004143: BC1 Bone Conductor (2000-1)
• 05711781004136: IN1 Insert Earphone (2000-1)
• 05711781004105: CA1 Audiometric Headphone (2000-1)