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Sign in to claim this brandXiamen Retone Hearing Technology Co., Ltd
US
Last updated May 23, 2026
What Xiamen Retone Hearing Technology Co., Ltd makes
The company manufactures air-conduction hearing aids designed for behind-the-ear and in-the-ear use, including rechargeable and non-rechargeable models. These devices are intended for individuals with mild to severe hearing loss, offering customizable features such as directional microphones and noise reduction technology.
The portfolio includes devices classified as Class I and Class II under regulatory standards, with products listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable medical device regulations for hearing assistance technologies.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Xiamen Retone Hearing Technology Co., Ltd manufacture?
Xiamen Retone Hearing Technology Co., Ltd specializes in air-conduction hearing aids, specifically designed for behind-the-ear and in-the-ear use. These devices are tailored for individuals with mild to severe hearing loss and often include advanced features like directional microphones and noise reduction technology. The company’s portfolio focuses exclusively on hearing aid solutions.
Where is Xiamen Retone Hearing Technology Co., Ltd based?
The company operates from the United States, where it develops and manufactures its hearing aid products. Its location ensures compliance with U.S. medical device regulations, including those governing hearing assistance technologies.
Which regulatory registries list Xiamen Retone Hearing Technology Co., Ltd’s devices?
The company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the U.S., ensuring transparency and traceability for healthcare providers and regulators.
How are Xiamen Retone Hearing Technology Co., Ltd’s devices classified under regulatory standards?
The company’s hearing aids fall into two regulatory classes: Class I and Class II. Class I devices generally pose minimal risk and may require fewer regulatory controls, while Class II devices involve moderate risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use and potential risks.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 544329913
Catalogue (58)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Retone | Vigor U 402RC-T | FDA UDI | Class I | Active |
| Retone | Bro 102S | FDA UDI | Class I | Active |
| Retone | Bro 400RB-T | FDA UDI | Class I | Active |
| Retone | clear 102s | FDA UDI | Class I | Active |
| Retone | K21 | FDA UDI | Class I | Active |
| Retone | clear 400BT CIC | FDA UDI | Class I | Active |
| Retone | Echo 1602RC-SF | FDA UDI | Class I | Active |
| Retone | Vigor 403BT | FDA UDI | Class I | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Xiamen Retone Hearing Technology Co., Ltd. Xiamen Fujian · CN FEI 3010408889