FDA Registration
Active
🇨🇳 China
NAMIC flexCIL Contrast Injection Lines (Braided Tubing)
Reg #: 3011871573
·
FEI: 3011871573
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- NANTONG ENOVE PRECISION PLASTIC CATHETER CO, LTD
- Registration Number
- 3011871573
- FEI Number
- 3011871573
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Building #7, No.30, Zilang Road, Chongchuan District
- City
- Nantong City Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K822100
Owner / Operator
- Firm Name
- Nantong Enove Precision Plastic Catheter Co, LTD
- Operator Number
- 10089785
- Address
- West 3rd Fl, Building #11, No.30 Zilang Road, Chongchuan District
- City
- Nantong City
- State
- Jiangsu
- Postal Code
- 226004
- Country
- CN
- Correspondent
- Tony Sun
US Agent
- Business Name
- Simcon International LLC
- Contact Name
- Rosanna Lee
- Address
- 1200 Townline Road
- City
- Mundelein
- State
- IL
- ZIP
- 60060
- Country
- US
- [email protected]
- Phone
- 847 9492290
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2024-01-08 |
Proprietary Names
NAMIC flexCIL Contrast Injection Lines (Braided Tubing)
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device