IFLYTEK

GUDID 16945936705616

Xiamen New Sound Technology Co., Ltd.

Air-conduction hearing aid, behind-the-ear

• Primary Device ID: 16945936705616
• NIH Device Record Key: cde47a74-dd08-4829-bdb6-6d8f75e246bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IFLYTEK
• Version Model Number: VAN 203 Pro
• Company DUNS: 528181200
• Company Name: Xiamen New Sound Technology Co., Ltd.
• Device Count: 2
• 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	06945936705619 [Primary]
GS1	16945936705616 [Unit of Use]

FDA Product Code

• OSM: Hearing Aid, Air-Conduction With Wireless Technology, Prescription

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: 2025-12-10
• Device Publish Date: 2025-12-02

On-Brand Devices [IFLYTEK]

• 16945936705616: VAN 203 Pro
• 16945936705609: VAN 610 Pro