HEARITE

GUDID 16971094537684

Huizhou Jinghao Medical Technology Co., Ltd

Air-conduction hearing aid, behind-the-ear

• Primary Device ID: 16971094537684
• NIH Device Record Key: 5e905ae7-dd45-483e-a53e-5ada13a3bb22
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HEARITE
• Version Model Number: JH-DW3F
• Company DUNS: 547508199
• Company Name: Huizhou Jinghao Medical 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: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: true
• 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	06971094537687 [Primary]
GS1	16971094537684 [Package]; Contains: 06971094537687; Package: [50 Units]; In Commercial Distribution

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: 2024-07-25
• Device Publish Date: 2024-07-17

Devices Manufactured by Huizhou Jinghao Medical Technology Co., Ltd

• 16971094538100 - NewHear: 2025-04-23
• 16971094538117 - BIBIED: 2025-04-22
• 16971094539428 - JINGHAO: 2025-04-21
• 06971094539414 - JINGHAO: 2025-04-11
• 16971094538087 - OXILINE: 2025-04-01
• 16971094538094 - OXILINE: 2025-04-01
• 16971094538025 - equate: 2025-03-24
• 16971094538018 - Premium health: 2025-03-21