FDA Registration
Active
🇨🇳 China
Hearing Aid(6116A, 6118, 7116T, 7116, 1216TE, 5001H, 5001L, 508OE, 5116A, 5116B, 5216A, 5216B, 5216C, 5116AE, 5216AE)
Reg #: 3037024831
·
FEI: 3037024831
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- SHENZHEN NINGJU MEDICAL ELECTRONIC CO.,LTD
- Registration Number
- 3037024831
- FEI Number
- 3037024831
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- A-1506, Huafeng Headquarters Economic Building, No. 288 Xixiang Avenue, Xixiang Street, Bao'an District
- City
- Shenzhen Guangdong
- Country
- CN
Owner / Operator
- Firm Name
- Shenzhen Ningju Medical Electronic Co.,Ltd
- Operator Number
- 10092826
- Address
- A-1506, Huafeng Headquarters Economic Building, No. 288 Xixiang Avenue, Xixiang Street, Bao'an District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518102
- Country
- CN
- Correspondent
- Anna Anna
US Agent
- Business Name
- SPICA MEDTECH CORP
- Contact Name
- Creekon Yang
- Address
- 1020 LINCOLN ST
- City
- Denver
- State
- CO
- ZIP
- 80203
- Country
- US
- [email protected]
- Phone
- 720 6176666
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 | 2025-02-23 |
Proprietary Names
Hearing Aid(6116A, 6118, 7116T, 7116, 1216TE, 5001H, 5001L, 508OE, 5116A, 5116B, 5216A, 5216B, 5216C, 5116AE, 5216AE)
Hearing Aid (NJ-316A, NJ-416D, NJ-416A, NJ-516D, NJ-516A, NJ-616D, NJ616A, NJ-716D, NJ-716A)
Hearing Aid (NJ-816D, NJ-816A, NJ-916D, NJ-916A, NJ-116D,NJ-116A,NJ-216D, NJ-216A, NJ-316D)
Hearing Aid(108, 1108A, 1108B, 308, 3308A, 3308B, 316, 216, 1208A, 1208B, 1216AE, 1216BE, 1118, 1120, 1122, 1124, 6116)
Hearing Aid(1126, 1128, 6120, 6121, 6122, 6126, 6128, 5222, 5220, 5003, 5005, 5006, 5122)
Hearing Aid(5118L, 5118H, 5118DL, 5118DH, 5116DL, 5116DH, 5126H, 5126L, 5128H, 5128L, 5120L, 5120H, 5116L, 5116H, 816TE)
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device