Retone
GUDID 16974308960025
Xiamen Retone Hearing Technology Co., Ltd.
Air-conduction hearing aid, in-the-ear| Primary Device ID | 16974308960025 |
| NIH Device Record Key | b980e10e-8c40-4dff-a41b-fa8ff9d6484f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Retone |
| Version Model Number | Vigor 402BT-RC |
| Company DUNS | 544329913 |
| Company Name | Xiamen Retone Hearing 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 | 16974308960025 [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 | 2025-02-03 |
| Device Publish Date | 2025-01-24 |
On-Brand Devices [Retone ]
Trademark Results [Retone]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RETONE 97193401 not registered Live/Pending |
Xiamen Retone Hearing Technology Co., Ltd. 2021-12-28 |
 RETONE 87103587 5449154 Live/Registered |
RESTORATION DERMACARE LLC 2016-07-14 |
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