TUITUI Hearing

GUDID 06974608620059

The hearing aid consists of the host and its accessories. The host comprises of the microphone, signal processor, battery, shell and receiver, and accessories, including the earplugs, cerumen baffle, charging box and charging cable. After inspection and fitting, the hearing aids is applicable for patients with air conduction hearing loss

Shenzhen Eartech Co., Ltd.

Air-conduction hearing aid, receiver-in-canal

• Primary Device ID: 06974608620059
• NIH Device Record Key: 9f866910-dcf4-4657-a32c-8f4b33403db4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TUITUI Hearing
• Version Model Number: ZTQ01ZT
• Company DUNS: 419851619
• Company Name: Shenzhen Eartech 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06974608620059 [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: 2025-05-08
• Device Publish Date: 2025-04-30

Devices Manufactured by Shenzhen Eartech Co., Ltd.

• 06974608620059 - TUITUI Hearing: 2025-05-08The hearing aid consists of the host and its accessories. The host comprises of the microphone, signal processor, battery, shell and receiver, and accessories, including the earplugs, cerumen baffle, charging box and charging cable. After inspection and fitting, the hearing aids is applicable for patients with air conduction hearing loss
• 06974608620059 - TUITUI Hearing: 2025-05-08 The hearing aid consists of the host and its accessories. The host comprises of the microphone, signal processor, battery, shell
• 06974608620004 - TUITUI: 2025-02-20
• 06974608620011 - TUITUI: 2025-02-20
• 06974608620028 - TUITUI: 2025-02-20
• 06974608623067 - TUITUI: 2025-02-14 The hearing aid consists of the host and its accessories. The host comprises of the microphone, signal processor, battery, shell