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Sign in to claim this brandXiamen Melosound Technology CO., Ltd
US
Last updated May 27, 2026
What Xiamen Melosound Technology CO., Ltd makes
Xiamen Melosound Technology CO., Ltd manufactures air-conduction hearing aids designed for in-the-ear and behind-the-ear use. These devices are intended to amplify sound for individuals with hearing loss, providing customised auditory support in both discreet and traditional form factors.
The company’s products are regulated under the FDA’s UDI system, with devices classified as Class I and Class II. These hearing aids are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with US medical device regulations.
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 Melosound Technology CO., Ltd manufacture?
Xiamen Melosound Technology CO., Ltd specialises in air-conduction hearing aids, specifically designed for in-the-ear and behind-the-ear use. These devices are intended to amplify sound for individuals experiencing hearing loss, offering solutions in both discreet and more traditional form factors.
Where is Xiamen Melosound Technology CO., Ltd based?
The company is based in the United States. While the name suggests an origin in Xiamen, China, the operational headquarters and regulatory filings are conducted from within the US.
Which regulatory registries list Xiamen Melosound Technology CO., Ltd’s devices?
The company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and compliance with US medical device regulations, allowing for tracking and verification of individual products.
How are Xiamen Melosound Technology CO., Ltd’s hearing aids classified under US regulations?
The company’s hearing aids fall under two classification tiers in the US: Class I and Class II. These classifications determine the regulatory controls applied to ensure safety and effectiveness, with Class II devices typically requiring additional scrutiny due to moderate risk.
Why are Xiamen Melosound Technology CO., Ltd’s devices included in the FDA’s UDI system?
The FDA’s UDI system assigns unique identifiers to medical devices to improve tracking, reduce medical errors, and enhance post-market surveillance. Including hearing aids like those from Xiamen Melosound Technology CO., Ltd ensures transparency in the supply chain and compliance with regulatory requirements for air-conduction hearing devices.
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
- 551745815
Catalogue (36)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Melosound | BTE UP | FDA UDI | Class I | Active |
| Melosound | Modo RM1600M BA | FDA UDI | Class II | Active |
| Melosound | Muse 1600M RIC | FDA UDI | Class I | Active |
| Melosound | ITE | FDA UDI | Class I | Active |
| melosound | Pingu 21 OF | FDA UDI | Class I | Active |
| Melosound | Peri P11S | FDA UDI | Class I | Active |
| Melosound | Luna RL40M | FDA UDI | Class I | Active |
| Melosound | LUNA RL21M | FDA UDI | Class I | Active |
| Melosound | Muse 80M RIC | FDA UDI | Class I | Active |
| Melosound | Faceplate | FDA UDI | Class I | Active |
| Melosound | Muse 1200M RIC | FDA UDI | Class I | Active |
| Melosound | ARIC P | FDA UDI | Class I | Active |
| Melosound | Luna RL1200M | FDA UDI | Class I | Active |
| Melosound | Modo RM40M | FDA UDI | Class I | Active |
| Melosound | Pingu 80 B | FDA UDI | Class I | Active |
| Melosound | Muse 1600P RIC | FDA UDI | Class I | Active |
| Melosound | Modo RM1200M B | FDA UDI | Class II | Active |
| Melosound | Luna RL1600M | FDA UDI | Class I | Active |
| Melosound | Popo RP40M | FDA UDI | Class I | Active |
| Melosound | Modo RM60M | FDA UDI | Class I | Active |
| Melosound | Muse 1200P RIC | FDA UDI | Class I | Active |
| Melosound | BTE SP | FDA UDI | Class I | Active |
| Melosound | Modo RM1600M B | FDA UDI | Class II | Active |
| Melosound | BTE P | FDA UDI | Class I | Active |
| melosound | Luna RL60M | FDA UDI | Class I | Active |
| Melosound | ITC-P | FDA UDI | Class I | Active |
| Melosound | Luna RL11M | FDA UDI | Class I | Active |
| Melosound | Modo RM1200M BA | FDA UDI | Class II | Active |
| melosound | Swan RS11P | FDA UDI | Class I | Active |
| Melosound | CIC | FDA UDI | Class I | Active |
| Melosound | Muse 80P RIC | FDA UDI | Class I | Active |
| Melosound | ITC | FDA UDI | Class I | Active |
| Melosound | CIC-P | FDA UDI | Class I | Active |
| Melosound | Luna RL80M | FDA UDI | Class I | Active |
| Melosound | Pingu 80 OF | FDA UDI | Class I | Active |
| Melosound | Pingu 40 OF | FDA UDI | Class I | Active |
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