FDA Registration
Active
🇨🇳 China
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
Reg #: 3017903826
·
FEI: 3017903826
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- KUNWEI MEDICAL ELECTRONICS CO.,LTD
- Registration Number
- 3017903826
- FEI Number
- 3017903826
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Room 1402, Block B, Builiding 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, Builiding 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
- 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, Prescription | ESD | Class 1 | Ear, Nose, Throat | No | 2020-11-12 |
Proprietary Names
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
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
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)