FDA Registration
Active
🇨🇳 China
Behind-The-Ear Hearing Aid, model: KD-17A,KD-27,KD-37,KD-57,KD-67,KD-87,KD-97
Reg #: 3017903826
·
FEI: 3017903826
·
Expires 2025
Products
1
Proprietary Names
3
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, Over The Counter | QUF | Class 1 | Ear, Nose, Throat | No | 2022-12-07 |
Proprietary Names
Behind-The-Ear Hearing Aid, model: KD-17A,KD-27,KD-37,KD-57,KD-67,KD-87,KD-97
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
In-The-Ear Hearing Aid, model: KV-701,KV-702,KG-71A,KG-73,KG-75,KG-76,KG-77,KG-78,KG-79
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)