FDA Registration
Active
🇨🇳 China
XIAMEN MELOSOUND TECHNOLOGY CO.,LTD
Reg #: 3014844046
·
FEI: 3014844046
·
Expires 2026
Products
4
Proprietary Names
6
Establishment Types
3
Classifications
4
Registration Details
- Registration Name
- XIAMEN MELOSOUND TECHNOLOGY CO.,LTD
- Registration Number
- 3014844046
- FEI Number
- 3014844046
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Room 117A,North Chuangye Building,Chuangye Park,Torch-Tech Zone
- City
- Xiamen Fujian
- Country
- CN
Owner / Operator
- Firm Name
- XIAMEN MELOSOUND TECHNOLOGY CO.,LTD
- Operator Number
- 10058640
- Address
- Room 117a,North Chuangye Building,, Chuangye Park,Torch-Tech Zone
- City
- Xiamen
- State
- Fujian
- Postal Code
- 361005
- Country
- CN
- Correspondent
- Kim Su
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.,
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hearing Aid, Air-Conduction, Over The Counter | QUF | Class 1 | Ear, Nose, Throat | No | 2022-11-22 |
| Face Plate Hearing Aid | LRB | Class 1 | Ear, Nose, Throat | No | 2018-10-17 |
| Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter | QUG | Class 2 | Ear, Nose, Throat | No | 2022-11-22 |
| Hearing Aid, Air-Conduction, Prescription | ESD | Class 1 | Ear, Nose, Throat | No | 2018-10-17 |
Proprietary Names
Muse 3200M, Muse 3200MB, ARIC 907, ARIC 909B, Duronix 1600 Ric, Duronix 3200 Ric, Duronix 1600 BT, Duronix 3200 BT
In-The-Ear Hearing Aid, ITE, ITC-P, ITC, CIC-P, CIC, Luna RL11M, Luna 1600M, Luna 3200M, Luna 3200MB, Zeal ONE;
Behind-The-Ear Hearing Aid, BTE UP, BTE SP, BTE P, ARIC P, Sonix 107, Sonix 707, Sonix 907, Sonix 909B, Muse1600M,
In-The-Ear Hearing Aid
In-The-Ear Hearing Aid; Behind-The-Ear Hearing Aid
Behind-The-Ear Hearing Aid; Body- worn Hearing aid; In-The-Ear Hearing Aid (Faceplate Kits Included)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device