AISENG

GUDID 06975958550690

Xiamen Mirasing Technology Co.,Ltd.

Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear

• Primary Device ID: 06975958550690
• NIH Device Record Key: 8f9031fe-4f58-4c3c-a101-7873b6d76b44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AISENG
• Version Model Number: F23D3
• Company DUNS: 701707532
• Company Name: Xiamen Mirasing 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: false
• 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	06975958550690 [Primary]

FDA Product Code

• QUF: Hearing Aid, Air-Conduction, 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: 2023-11-30
• Device Publish Date: 2023-11-22

Devices Manufactured by Xiamen Mirasing Technology Co.,Ltd.

• 06975958550065 - Incensonic: 2024-06-04
• 06975958550508 - Incensonic: 2024-06-04
• 06975958550553 - Mirasing: 2024-04-16
• 06975958550690 - AISENG: 2023-11-30
• 06975958550690 - AISENG: 2023-11-30
• 06975958550683 - AUSTONE: 2023-07-10
• 06975958550072 - Digital Hearing Aids: 2023-05-22
• 06975958550089 - Digital Hearing Aids: 2023-05-22
• 06975958550096 - Digital Hearing Aids: 2023-05-22