FDA Registration
Active
🇨🇳 China
Electrode pads
Reg #: 3013671142
·
FEI: 3013671142
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SHENZHEN KENTRO MEDICAL ELECTRONICS CO., LTD
- Registration Number
- 3013671142
- FEI Number
- 3013671142
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2nd Floor, No. 11, Shanzhuang Road, Xikeng Village, Yuanshan Street, Longgang District
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K171381
Owner / Operator
- Firm Name
- SHENZHEN KENTRO MEDICAL ELECTRONICS CO., LTD
- Operator Number
- 10055119
- Address
- 2nd Floor, No. 11, Shanzhuang Road, Xikeng Village, Yuanshan Street, Longgang District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518115
- Country
- CN
- Correspondent
- Zewu Zhang
US Agent
- Business Name
- MID-LINK INTERNATIONAL Co.,Ltd
- Contact Name
- Marco Mu
- Address
- 2219 Rimlang Drive, Suite 301
- City
- Bellingham
- State
- WA
- ZIP
- 98226
- Country
- US
- [email protected]
- Phone
- 702 2095185
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2022-05-23 |
Proprietary Names
Electrode pads
Electrode pads (RHB2029PAK2, RHB2029PAK20)
Establishment Types
Export Device to the United States But Perform No Other Operation on Device