RETEKESS

GUDID 16971094537790

Huizhou Jinghao Medical Technology Co., Ltd

Air-conduction hearing aid, in-the-ear

• Primary Device ID: 16971094537790
• NIH Device Record Key: 4945ce17-4e2e-493e-9ebb-19683eaf3e99
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RETEKESS
• 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: true
• 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	06971094537793 [Primary]
GS1	16971094537790 [Package]; Contains: 06971094537793; Package: [50 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: 2024-09-10
• Device Publish Date: 2024-09-02

Devices Manufactured by Huizhou Jinghao Medical Technology Co., Ltd

• 16971094537943 - FLAYGO: 2024-12-23
• 16971094537936 - FLAYGO: 2024-12-10
• 16971094537929 - Dimora: 2024-12-04
• 06971094539216 - JINGHAO: 2024-11-25
• 16971094537905 - Oricle: 2024-11-12
• 16971094537868 - PWTEK: 2024-11-08
• 16971094537875 - Hotsch: 2024-11-08
• 16971094537899 - Oricle: 2024-11-08