FDA Registration
Active
🇨🇳 China
KUNWEI MEDICAL ELECTRONICS CO.,LTD
Reg #: 3017903826
·
FEI: 3017903826
·
Expires 2026
Products
3
Proprietary Names
7
Establishment Types
3
Classifications
3
Registration Details
- Registration Name
- KUNWEI MEDICAL ELECTRONICS CO.,LTD
- Registration Number
- 3017903826
- FEI Number
- 3017903826
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Room 1402, Block B, Building 2, Longgang Tianan Cyber Park, Huangge Road, Longgang District
- City
- Shenzhen Guangdong
- Country
- CN
Owner / Operator
- Firm Name
- Kunwei Medical Electronics Co.,Ltd
- Operator Number
- 10078957
- Address
- Room 1402, Block B, Building 2, Longgang Tianan Cyber Park, Huangge Road, Longgang District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518172
- Country
- CN
- Correspondent
- Kenson Zhao
US Agent
- Business Name
- HyperCert Limited
- Contact Name
- Noah Zhang
- Address
- 16192 Coastal Hwy
- City
- Lewes
- State
- DE
- ZIP
- 19958
- Country
- US
- [email protected]
- Phone
- 863 3233636
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hearing Aid, Air-Conduction, Prescription | ESD | Class 1 | Ear, Nose, Throat | No | 2020-11-12 |
| Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter | QUG | Class 2 | Ear, Nose, Throat | No | 2022-12-07 |
| Hearing Aid, Air-Conduction, Over The Counter | QUF | Class 1 | Ear, Nose, Throat | No | 2022-12-07 |
Proprietary Names
Hearing Aids: KV-601, KV-602, KV-603, KV-701, KV-702, KV-703, KV-801, KV-802, KV-803, KV-901, KV-902, KV-903
Hearing Aids: KV-201, KV-202, KV-203, KV-301,KV-302, KV-303, KV-401, KV-402, KV-403,KV-501, KV-502, KV-503
In-The-Ear Hearing Aid, model: KG-71B,KG-73B,KG-75B,KG-76B,KG-77B,KG-78B,KG-79B
Behind-The-Ear Hearing Aid, model: KD-17B,KD-27B,KD-37B,KD-57B,KD-67B,KD-87B,KD-97B,KV-306B,KV-307B,KV-308B,KV-309B
In-The-Ear Hearing Aid, model: KV-701,KV-702,KG-71A,KG-73,KG-75,KG-76,KG-77,KG-78,KG-79
Behind-The-Ear Hearing Aid, model: KV-202,KV-301A,KV-303A,KV-305A,KV-401A,KV-403A,KV-405A,KV-301,KV-303,KV-305,KV-401
Behind-The-Ear Hearing Aid, model: KD-17A,KD-27,KD-37,KD-57,KD-67,KD-87,KD-97
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)