HARMONIX

GUDID 06971094538561

Huizhou Jinghao Medical Technology Co., Ltd

Air-conduction hearing aid, in-the-ear

• Primary Device ID: 06971094538561
• NIH Device Record Key: 560fa795-693e-4a52-ac96-4b973586ac4a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HARMONIX
• Version Model Number: JH-A32E
• Company DUNS: 547508199
• Company Name: Huizhou Jinghao Medical Technology Co., Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971094538561 [Primary]
GS1	16971094538568 [Package]; Package: [3 Units]; In Commercial Distribution
GS1	26971094538565 [Package]; Contains: 16971094538568; Package: [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221052

FDA Product Code

• QUH: Self-Fitting Air-Conduction Hearing Aid, 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: 2026-01-28
• Device Publish Date: 2026-01-20

Devices Manufactured by Huizhou Jinghao Medical Technology Co., Ltd

• 06971094538561 - HARMONIX: 2026-01-28
• 06971094538561 - HARMONIX: 2026-01-28
• 06971094538530 - LITOULF: 2025-12-29
• 06971094539483 - JINGHAO: 2025-12-16
• 16971094538506 - Nacenacy: 2025-12-09
• 16971094538513 - Nacenacy Villear: 2025-12-09
• 06971094539452 - JINGHAO: 2025-10-02
• 06971094538431 - Soundure: 2025-09-23
• 06971094538448 - Soundure: 2025-09-23