FDA Registration
Active
🇨🇳 China
Electrode, electrocardiograph
Reg #: 3004537821
·
FEI: 3004537821
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- SHANGHAI INTCO ELECTRODE MANUFACTURING CO LTD
- Registration Number
- 3004537821
- FEI Number
- 3004537821
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No. 1358, Hubin Road, Fengxian District
- City
- Shanghai
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K093327
Owner / Operator
- Firm Name
- Shanghai Intco Electrode Manufacturing Co Ltd
- Operator Number
- 10044050
- Address
- No. 1358 Hubin Road, Fengxian
- City
- Shanghai
- State
- CN-SH
- Postal Code
- 201417
- Country
- CN
- Correspondent
- Max Li
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2013-04-23 |
Proprietary Names
Electrode, electrocardiograph
eletrode
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device