Retone, Nerboo

GUDID 16974308960322

Xiamen Retone Hearing Technology Co., Ltd.

Air-conduction hearing aid, in-the-ear

• Primary Device ID: 16974308960322
• NIH Device Record Key: f2a32ab7-6f19-4f97-af25-e6bf9f25247b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Retone, Nerboo
• Version Model Number: K419
• Company DUNS: 544329913
• Company Name: Xiamen Retone Hearing Technology Co., Ltd.
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	16974308960322 [Primary]

FDA Product Code

• QUF: Hearing Aid, Air-Conduction, Over The Counter

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: 2025-02-03
• Device Publish Date: 2025-01-24

Devices Manufactured by Xiamen Retone Hearing Technology Co., Ltd.

• 06974308960004 - Retone: 2025-02-03
• 06974308960011 - Retone: 2025-02-03
• 06974308960028 - Retone: 2025-02-03
• 06974308960035 - Retone: 2025-02-03
• 06974308960042 - Retone: 2025-02-03
• 06974308960059 - Retone: 2025-02-03
• 06974308960066 - Retone: 2025-02-03
• 06974308960073 - Retone: 2025-02-03