Retone

GUDID 16974308960193

Xiamen Retone Hearing Technology Co., Ltd

Air-conduction hearing aid, in-the-ear

• Primary Device ID: 16974308960193
• NIH Device Record Key: 60d5b383-573b-4769-aa28-967e9a4d8b48
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Retone
• Version Model Number: Smart 1604LE
• 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	16974308960193 [Primary]

FDA Product Code

• QUG: Hearing Aid, Air-Conduction With Wireless Technology, 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: 2026-01-16
• Device Publish Date: 2026-01-08

On-Brand Devices [Retone ]

• 16974308960162: Bro 102S
• 16974308960193: Smart 1604LE