FDA Registration
Active
🇨🇳 China
ITE Hearing Aid: GM-901T,GM-902T,GM-903T,GM-904T,GM-911T,GM-912T,GM-913T,GM-914T,GM-915T,GM-920T,GM-921T,GM-922T,GM-923T
Reg #: 3017610929
·
FEI: 3017610929
·
Expires 2025
Products
1
Proprietary Names
15
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, Over The Counter | QUF | Class 1 | Ear, Nose, Throat | No | 2022-11-16 |
Proprietary Names
ITE Hearing Aid: GM-901T,GM-902T,GM-903T,GM-904T,GM-911T,GM-912T,GM-913T,GM-914T,GM-915T,GM-920T,GM-921T,GM-922T,GM-923T
Hearing Aid, Air-Conduction, Over the Counter:Behind-the-ear (BTE) Hearing Aid,Models GM-361T,GM-362T,GM-363T,GM-370T
Hearing Aid, Air-Conduction, Over the Counter:Behind-the-ear (BTE) Hearing Aid,Models:GM-312T,GM-313T,GM-314T,GM-320T
Hearing Aid, Air-Conduction, Over the Counter:Behind-the-ear (BTE) Hearing Aid,Models:GM-306T,GM-307T,GM-310T,GM-311T
ITE Hearing Aid:GM-991T,GM-992T,GM-993T
ITE Hearing Aid: GM-930T,GM-931T,GM-932T,GM-933T,GM-934T,GM-940T,GM-941T,GM-942T,GM-950T,GM-951T,GM-951T,GM-952T,GM-953T
Hearing Aid, Air-Conduction, Over the Counter:Behind-the-ear (BTE) Hearing Aid,Models GM-351T,GM-352T,GM-353T,GM360T
Hearing Aid, Air-Conduction, Over the Counter:Behind-the-ear (BTE) Hearing Aid,Models GM-341T,GM-342T,GM-343T,GM-350T,
Hearing Aid, Air-Conduction, Over the Counter:Behind-the-ear (BTE) Hearing Aid,Models GM-371T,GM-372T,GM-373T,GM-380T
ITE Hearing Aid:GM-960T,GM-961T,GM-962T,GM-963T,GM-970T,GM-971T,GM972T,GM-973T,GM-980T,GM-981T,GM-982T,GM-983T,GM-990T
Hearing Aid, Air-Conduction, Over the Counter:Behind-the-ear (BTE) Hearing Aid,Models GM-331T,GM-332T,GM-333T,GM-340T
Hearing Aid, Air-Conduction, Over the Counter:Behind-the-ear (BTE) Hearing Aid,Models:GM-301T,GM-302T,GM-303T,GM-304T
Hearing Aid, Air-Conduction, Over the Counter:Behind-the-ear (BTE) Hearing Aid,Models GM-321T,GM322T,GM-323T,GM-330T
Hearing Aid, Air-Conduction, Over the Counter:Behind-the-ear (BTE) Hearing Aid,Models GM-381T,GM382T,GM-383T,GM-390T
Hearing Aid, Air-Conduction, Over the Counter:Behind-the-ear (BTE) Hearing Aid,Models GM-391T,GM-392T,GM-393T
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