WENKEY

GUDID 06945936703363

Xiamen New Sound Technology Co., Ltd.

Air-conduction hearing aid, in-the-ear

• Primary Device ID: 06945936703363
• NIH Device Record Key: bfaa4962-1a8c-4c13-a410-86b6dd6a5803
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WENKEY
• Version Model Number: WE-601
• 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	06945936703363 [Unit of Use]
GS1	16945936703360 [Primary]

FDA Product Code

• OSM: Hearing Aid, Air Conduction With Wireless Technology

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: 2022-09-16
• Device Publish Date: 2022-09-08

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

• 16945936704060 - Nano: 2024-05-29
• 16945936704077 - Nano: 2024-05-29
• 16945936704084 - Nano: 2024-05-29
• 16945936704053 - Newsound: 2024-05-20
• 16945936703889 - Newsound: 2024-03-28
• 06945936703899 - Newsound: 2024-03-28
• 06945936703776 - Newsound: 2024-01-29
• 06945936702236 - Newsound: 2023-12-13