FDA Registration
Active
🇨🇳 China
Ureteral Access Sheath With Suction Collection
Reg #: 3035480112
·
FEI: 3035480112
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SEPLOU (ZHUHAI) CO.,LTD.
- Registration Number
- 3035480112
- FEI Number
- 3035480112
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5th Floor, Building 1, No. 8, Keji 10th Road, Tangjiawan Town, High-tech Zone
- City
- Zhuhai Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K243025
Owner / Operator
- Firm Name
- SEPLOU (ZHUHAI) CO.,LTD.
- Operator Number
- 10092239
- Address
- 5th Floor, Building 1, No. 8, Keji 10th Road, Tangjiawan Town, High-tech Zone
- City
- Zhuhai
- State
- Guangdong
- Postal Code
- 519085
- Country
- CN
- Correspondent
- Vince Zeng
US Agent
- Business Name
- SEPLOU, Inc.
- Contact Name
- Jim Griffin
- Address
- 255 North Trade Street, Suite C
- City
- Tryon
- State
- NC
- ZIP
- 28782
- Country
- US
- [email protected]
- Phone
- 404 6979649
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | Class 2 | Gastroenterology, Urology | No | 2025-04-10 |
Proprietary Names
Ureteral Access Sheath With Suction Collection
Ureteral Access Sheath
Establishment Types
Manufacture Medical Device