FDA Registration
Active
🇨🇳 China
ZHONGSHAN GREAT-EARS ELECTRONIC TECHNOLOGY CO.,LTD
Reg #: 3013596029
·
FEI: 3013596029
·
Expires 2026
Products
3
Proprietary Names
40
Establishment Types
3
Classifications
3
Registration Details
- Registration Name
- ZHONGSHAN GREAT-EARS ELECTRONIC TECHNOLOGY CO.,LTD
- Registration Number
- 3013596029
- FEI Number
- 3013596029
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3rd/F No. 35 West Road, Dongsheng Tongmao Industrial Park, Xiao Lan Town
- City
- Zhongshan Guangdong
- Country
- CN
Owner / Operator
- Firm Name
- Zhongshan Great-ears Electronic Technology Co.,Ltd
- Operator Number
- 10053886
- Address
- 3rd/F No. 35 West Road, Dongsheng Tongmao Industrial Park, Xiao Lan Town
- City
- Zhongshan
- State
- Guangdong
- Postal Code
- 528401
- Country
- CN
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
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 | 2022-12-29 |
| Hearing Aid, Air-Conduction, Prescription | ESD | Class 1 | Ear, Nose, Throat | No | 2017-01-19 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2026-06-02 |
Proprietary Names
G-51, G-52, G-53, G-55, G-56, G-57, G-59, G-60, G-70, G-72, G-73, G-75, G-75D, G-76, G-77, G-79, G-90, G-92, G-93, G-95,
G-96, G-97, G-99
G-10, G-11, G-11L, G-12, G-13, G-15, G-16, G-16D, G-17, G-17D, G-18, G-18C, G-18D, G-19, G-19D, G-20, G-20B, G-21, G-22,
G-31, G-31L, G-32, G-32D, G-33, G-33D, G-35, G-36, G-36L, G-37, G-37D, G-39, G-50,
G-22D, G-23, G-25, G-25BT, G-25C, G-25D, G-25L, G-26, G-26C, G-27, G-27P, G-28, G-28C, G-28D, G-28RIC, G-29, G-29D, G-30
G-35, G-36, G-36L, G-37, G-37D, G-39, G-50
G-51, G-52, G-53, G-55, G-56, G-57, G-59, G-60, G-77, G-79, G-90, G-92, G-93, G-95, G-96, G-97, G-99
G-10, G-10L, G-11, G-11D, G-11L, G-12, G-13, G-13D, G-15, G-15D, G-15L, G-16, G-16C, G-16D, G-17, G-17D, G-18, G-18C,
G-18D, G-19, G-19D, G-20, G-20B, G-21, G-22, G-22D, G-23, G-23D, G-25, G-25BT, G-25C, G-25D, G-25L, G-26, G-26C, G-26D,
G-27, G-27D, G-27P, G-28, G-28C, G-28D, G-28L, G-28RIC, G-29, G-29D, G-30, G-30D, G-31, G-31L, G-32, G-32D, G-33, G-33D,
H10
M16
H19
RLT-SL
M11
H11
H12
Y11
H16
M17
H15
RLT-M210
Y16
RLT-JC101
M19
Y10
M15
Y17
Y12
H13
Y15
M12
RLT-M3600
Y13
M13
H17
RLT-M360
Y19
M10
RLT-JC70
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device