flysound

GUDID 06978516630025

Shenzhen Flysounds Medical Technology Co.,Ltd.

Air-conduction hearing aid, behind-the-ear

• Primary Device ID: 06978516630025
• NIH Device Record Key: cde441d2-52e3-4f11-b32a-9230666e1da9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: flysound
• Version Model Number: H8
• Company DUNS: 978407839
• Company Name: Shenzhen Flysounds Medical 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: 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06978516630025 [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: 2025-08-25
• Device Publish Date: 2025-08-15

On-Brand Devices [flysound]

• 06978516630032: H9
• 06978516630025: H8