FDA Registration
Active
🇨🇳 China
ITE Wireless Hearing Aid: GM--903A,GM-913A,GM-923A,GM-933A,GM-943A,GM-953A,GM-963A,GM-973A,GM-983A,GM-993A
Reg #: 3017610929
·
FEI: 3017610929
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- HONG YU KANG TECHNOLOGY (GUANGDONG) CO., LTD.
- Registration Number
- 3017610929
- FEI Number
- 3017610929
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Room 301,302,303, 3rd Floor, Building 12, Fuqiao Second District, Heping Community,Fuhai Street, Bao An,
- City
- Shenzhen Guangdong
- Country
- CN
Owner / Operator
- Firm Name
- Hong Yu Kang Technology (Guangdong) Co., Ltd.
- Operator Number
- 10078152
- Address
- Room 301,302,303, 3rd Floor, Building 12, Fuqiao Second District, Heping Community,Fuhai Street, Bao An,
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518103
- Country
- CN
- Correspondent
- Hongbo Zhang
US Agent
- Business Name
- M.Y.T. USA CORP
- Contact Name
- Christine Wang
- Address
- 15796 Canon Ln
- City
- Chino Hills
- State
- CA
- ZIP
- 91709
- Country
- US
- [email protected]
- Phone
- 918 9988916
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hearing Aid, Air-Conduction With Wireless Technology, Prescription | OSM | Class 2 | Ear, Nose, Throat | No | 2022-11-16 |
Proprietary Names
ITE Wireless Hearing Aid: GM--903A,GM-913A,GM-923A,GM-933A,GM-943A,GM-953A,GM-963A,GM-973A,GM-983A,GM-993A
Behind-the-ear (BTE) Wireless Hearing Aids, Models:GM-383A,GM-393A
Behind-the-ear (BTE) Wireless Hearing Aids, Models: GM-303A,GM-313A,GM-323A,GM-333A,GM-343A,GM-353A,GM-363A,GM-373A
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)