Is this your brand? Sign in to claim ownership.
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
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 544329913
Catalogue (58)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Retone | Vigor 402BT-RC | FDA UDI | Class I | Active |
| Retone, Nebroo | K1625BE | FDA UDI | Class II | Active |
| Retone | Eggo 202 | FDA UDI | Class I | Active |
| Retone | K419-N | FDA UDI | Class I | Active |
| Retone | clear 100 CIC | FDA UDI | Class I | Active |
| Retone | Echo 403RC | FDA UDI | Class I | Active |
| Retone | K239RC | FDA UDI | Class I | Active |
| Retone | K19RC | FDA UDI | Class I | Active |
| Retone, Nebroo | K159RC | FDA UDI | Class I | Active |
| Retone | Vigor 402RC-T | FDA UDI | Class I | Active |
| Retone | K219 | FDA UDI | Class I | Active |
| Retone | K218 | FDA UDI | Class I | Active |
| Retone | Vigor 402BT-P | FDA UDI | Class I | Active |
| Retone | Clear 216 | FDA UDI | Class I | Active |
| Retone | K269RC | FDA UDI | Class I | Active |
| Retone | Bro 402BT-RC | FDA UDI | Class I | Active |
| Retone | K216 | FDA UDI | Class I | Active |
| Retone | Vigor U 402 | FDA UDI | Class I | Active |
| Retone | Clear 101H | FDA UDI | Class I | Active |
| Retone | Gio 402BT | FDA UDI | Class I | Active |
| Retone, Nebroo | K419 | FDA UDI | Class I | Active |
| Retone | k18s | FDA UDI | Class I | Active |
| Retone | clear 101 CIC | FDA UDI | Class I | Active |
| Retone | Echo 402RC-T | FDA UDI | Class I | Active |
| Retone | K19S | FDA UDI | Class I | Active |
| Retone | clear 100 ITC | FDA UDI | Class I | Active |
| Retone | Gio 402 | FDA UDI | Class I | Active |
| Retone | Vigor 403 | FDA UDI | Class I | Active |
| Retone | Vigor U 403 | FDA UDI | Class I | Active |
| Retone | Bright 401P | FDA UDI | Class I | Active |
| Retone | Bro 202 | FDA UDI | Class I | Active |
| Retone | Bro 402RB-T | FDA UDI | Class I | Active |
| Retone | clear 107H | FDA UDI | Class I | Active |
| Retone | Vigor U 402BT | FDA UDI | Class I | Active |
| Retone | Vigor U 402BT-RC | FDA UDI | Class I | Active |
| Retone | Eggo 402BT | FDA UDI | Class I | Active |
| Retone | K259RB | FDA UDI | Class I | Active |
| Retone | K19B | FDA UDI | Class I | Active |
| Retone | Bright 601 | FDA UDI | Class I | Active |
| Retone | Eggo 402 | FDA UDI | Class I | Active |
| Retone | K20 | FDA UDI | Class I | Active |
| Retone | Smart U 1604 | FDA UDI | Class I | Active |
| Retone | Smart R 102BT | FDA UDI | Class I | Active |
| Retone | Clear 102H | FDA UDI | Class I | Active |
| Retone | Vigor 402BT | FDA UDI | Class I | Active |
| Retone | K218P | FDA UDI | Class I | Active |
| Retone | clear 101 ITC | FDA UDI | Class I | Active |
| Retone | K218SP | FDA UDI | Class I | Active |
| Retone | Vigor 402 | FDA UDI | Class I | Active |
| Retone | Vigor U 403BT | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
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