FDA Registration
Active
🇨🇳 China
Huizhou Jinghao Medical Technology Co., Ltd
Reg #: 3011586575
·
FEI: 3011586575
·
Expires 2026
Products
5
Proprietary Names
9
Establishment Types
4
Classifications
5
Registration Details
- Registration Name
- Huizhou Jinghao Medical Technology Co., Ltd
- Registration Number
- 3011586575
- FEI Number
- 3011586575
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 207, South SiHuan Rd, ZhongKai Hi-tech District
- City
- Huizhou Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K221052
Owner / Operator
- Firm Name
- Huizhou Jinghao Medical Technology Co., Ltd
- Operator Number
- 10048535
- Address
- No. 207, South SiHuan Rd, ZhongKai Hi-tech District
- City
- Huizhou
- State
- Guangdong
- Postal Code
- 516006
- Country
- CN
- Correspondent
- Shine Wang
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.,
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
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 | 2022-10-24 |
| Self-Fitting Air-Conduction Hearing Aid, Over The Counter | QUH | Class 2 | Ear, Nose, Throat | No | 2023-11-14 |
| Hearing Aid, Air-Conduction, Over The Counter | QUF | Class 1 | Ear, Nose, Throat | No | 2022-11-02 |
| Hearing Aid, Air-Conduction, Prescription | ESD | Class 1 | Ear, Nose, Throat | No | 2015-01-23 |
| Hearing Aid, Air-Conduction With Wireless Technology, Prescription | OSM | Class 2 | Ear, Nose, Throat | No | 2021-12-20 |
Proprietary Names
JH-D59ET,BRH-118,BRH-120
Hearing aid,amplifiers with models JH-AW2BT,JH-TW4AT,JH-DW1AT,JH-DW2AT,JH-DW3FT,JH-DW4AT,JH-D13B
JH-D58,JH-D59FT,JH-DW3F,JH-DW5A,JH-A61HT,JH-A40C,JH-A32E
JH-A170
Hearing aid,amplifiers with models JH-A17BT,JH-A32BT,JH-A39HT,JH-A61AT, JH-A62AT,JH-D26AT,JH-D35CT,JH-D59CT,JH-D12AT
JH-D36AT,JH-A17CT,JH-DW2ET,JH-A49A,JH-A490,CE-A18A,CE-A80B,JH-DW4E,JH-A260,JH-A26A,CE-A90A,JH-D260,JH-A420,JH-A26D
JH-A19A,BRH -007,BRH -124
JH-125,JH-115,JH-338
Hearing aid,amplifiers with models JH-DW1A, JH-DW3A
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
Complaint File Establishment per 21 CFR 820.198