FDA Registration
Active
🇨🇳 China
Latex Foley Catheter
Reg #: 3031175043
·
FEI: 3031175043
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- CATHWIDE MEDICAL CO.,LTD.
- Registration Number
- 3031175043
- FEI Number
- 3031175043
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 305A Building 9, No. 1888 Xinjinqiao Road
- City
- Shanghai
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K173340
Owner / Operator
- Firm Name
- Cathwide Medical Co.,Ltd.
- Operator Number
- 10092546
- Address
- 305A Building 9, No. 1888, Xinjinqiao Road
- City
- Shanghai
- State
- CN-NOTA
- Postal Code
- 201206
- Country
- CN
- Correspondent
- XINLEI WEI
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 |
|---|---|---|---|---|---|
| Catheter, Retention Type, Balloon | EZL | Class 2 | Gastroenterology, Urology | No | 2025-01-18 |
Proprietary Names
Latex Foley Catheter
Establishment Types
Export Device to the United States But Perform No Other Operation on Device