FDA Registration
Active
🇨🇳 China
XIAMEN VIENATONE MEDICAL TECHNOLOGY CO., LTD.
Reg #: 3030396448
·
FEI: 3030396448
·
Expires 2026
Products
5
Proprietary Names
26
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- XIAMEN VIENATONE MEDICAL TECHNOLOGY CO., LTD.
- Registration Number
- 3030396448
- FEI Number
- 3030396448
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 8th Floor, Block A, Jianye Building, No. 96 Xiangxing Road, Xiamen Torch High-Tech Zone (Xiang an) Industrial Zone
- City
- Xiamen Fujian
- Country
- CN
Owner / Operator
- Firm Name
- Xiamen Vienatone Medical Technology Co., Ltd.
- Operator Number
- 10089482
- Address
- 8th Floor, Block A, Jianye Building, No. 96 Xiangxing Road, Xiamen Torch High-Tech Zone (Xiang'an)Industrial Zone
- City
- Xiamen
- State
- Fujian
- Postal Code
- 361101
- Country
- CN
US Agent
- Business Name
- IRC USA
- Contact Name
- Charles Mack
- Address
- 2950 E Lindrick Dr.
- City
- Chandler
- State
- AZ
- ZIP
- 85249
- Country
- US
- [email protected]
- Phone
- 931 6254938
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Face Plate Hearing Aid | LRB | Class 1 | Ear, Nose, Throat | No | 2023-12-11 |
| Hearing Aid, Air-Conduction, Over The Counter | QUF | Class 1 | Ear, Nose, Throat | No | 2023-12-11 |
| Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter | QUG | Class 2 | Ear, Nose, Throat | No | 2023-12-11 |
| Hearing Aid, Air-Conduction, Prescription | ESD | Class 1 | Ear, Nose, Throat | No | 2023-12-11 |
| Hearing Aid, Air-Conduction With Wireless Technology, Prescription | OSM | Class 2 | Ear, Nose, Throat | No | 2023-12-11 |
Proprietary Names
FACE PLATE HEARING AID
LY CR230
TY CN430S
CN223
CN130S
Behind-The-Ear Hearing Aid
Samba R11
jiaquanCN430S
Mini series
In-The-Ear Hearing Aid
PISnet HearClean
Hearing Aid, Air-Conduction, Over The Counter
Falcon CF430S
E-08
Ballet series
Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter
ion Pro
Navo series
iBstone Edge series
ion Pro 2
Discovery series
Explore Li+
RC07-02
RC07-01
Hearing Aid, Air-Conduction
Hearing Aid, Air-Conduction With Wireless Technology, Prescription
Establishment Types
Manufacture Medical Device