RETEKESS

GUDID 16945936705623

Xiamen New Sound Technology Co., Ltd.

Air-conduction hearing aid, in-the-ear

• Primary Device ID: 16945936705623
• NIH Device Record Key: 3f42ef09-7752-4a81-8063-15b2e2ee7ffc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RETEKESS
• Version Model Number: TE103
• 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	06945936705626 [Primary]
GS1	16945936705623 [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: 2025-12-24
• Device Publish Date: 2025-12-16

Devices Manufactured by Xiamen New Sound Technology Co., Ltd.

• 16945936705623 - RETEKESS: 2025-12-24
• 16945936705623 - RETEKESS: 2025-12-24
• 16945936705609 - IFLYTEK: 2025-12-10
• 16945936705616 - IFLYTEK: 2025-12-10
• 16945936705296 - METIKO: 2025-09-10
• 16945936704886 - AHA Technologies: 2025-02-20
• 16945936704831 - PowerLix: 2024-12-19
• 06945936704742 - Newsound: 2024-12-06
• 06945936704759 - Newsound: 2024-12-06