FDA Registration
Active
🇨🇳 China
BTE Wireless Hearing Aid: GM-301,GM-302,GM-303,GM-304,GM-306,GM-307,GM-310,GM-311,GM-312,GM-313,GM-314,GM-320,GM-321
Reg #: 3017610929
·
FEI: 3017610929
·
Expires 2025
Products
1
Proprietary Names
9
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, Over The Counter | QUG | Class 2 | Ear, Nose, Throat | No | 2022-11-16 |
Proprietary Names
BTE Wireless Hearing Aid: GM-301,GM-302,GM-303,GM-304,GM-306,GM-307,GM-310,GM-311,GM-312,GM-313,GM-314,GM-320,GM-321
BTE Wireless Hearing Aid: GM322,GM-323,GM-330,GM-331,GM-332,GM-333,GM-340,GM-341,GM-342,GM-343,GM-350,GM-351,GM-352
Hearing Aid, Air-Conduction with Wireless Technology, Over the Counter
BTE Wireless Hearing Aid:GM-390,GM-391,GM-392,GM-393
ITE Wireless Hearing Aid:GM-960,GM-961,GM-962,GM-963,GM-970,GM-971,GM972,GM-973,GM-980,GM-981,GM-982,GM-983,GM-990
ITE Wireless Hearing Aid: GM-901,GM-902,GM-903,GM-904,GM-911,GM-912,GM-913,GM-914,GM-915,GM-920,GM-921,GM-922,GM-923
ITE Wireless Hearing Aid: GM-991,GM-992,GM-993
ITE Wireless Hearing Aid: GM-930,GM-931,GM-932,GM-933,GM-934,GM-940,GM-941,GM-942,GM-943,GM-950,GM-951,GM-952,GM-953
BTE Wireless Hearing Aid:GM-353,GM-360,GM-361,GM-362,GM-363,GM-370,GM-371,GM-372,GM-373,GM-380,GM-381,GM382,GM-383
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device