Ceretone

GUDID 06971094537489

Huizhou Jinghao Medical Technology Co., Ltd

Air-conduction hearing aid, in-the-ear

• Primary Device ID: 06971094537489
• NIH Device Record Key: ec3d8f45-3d28-4322-9ef0-098e7d7c4752
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ceretone
• Version Model Number: CE-A80B
• 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: 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	06971094537489 [Primary]
GS1	16971094537486 [Package]; Package: [40 Units]; In Commercial Distribution

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: 2023-06-12
• Device Publish Date: 2023-06-03

On-Brand Devices [Ceretone]

• 16971094537493: CE-A80B
• 06971094537489: CE-A80B