FDA Registration
Active
🇨🇳 China
Behind-the-ear (BTE) aids, models: GM-11,GM-111,GM-100A,GM-105,GM-130
Reg #: 3017610929
·
FEI: 3017610929
·
Expires 2025
Products
1
Proprietary Names
5
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, Prescription | ESD | Class 1 | Ear, Nose, Throat | No | 2020-10-12 |
Proprietary Names
Behind-the-ear (BTE) aids, models: GM-11,GM-111,GM-100A,GM-105,GM-130
Bluetooth hearing aids, models: GM-301,GM-302,GM-303,GM-304,GM-305,GM-307
In-the-ear (ITE) aids, models: GM-910,GM-900F,GM-900,GM-900E,GM-900C,GM-900G,GM-900B,GM-902,GM-904,GM-901A
Behind-the-ear (BTE) aids, models: GM-200,GM-201,GM-220,GM-230,GM-250,GM-270,GM-290,GM-291,GM-297,GM-299
In-the-ear (ITE) aids, models: GM-908,GM-903,GM-907,GM-912,GM-913,GM-914,GM-915,GM-916,GM-917,GM-918,GM-919,GM-920
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)