FDA Registration
Active
🇨🇳 China
CATHETER MALE POCKET16"STRTIP14KIT 30 US (M14UK)
Reg #: 3002993863
·
FEI: 3002993863
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Shaoxing Fuqing Health Products Co., Ltd.
- Registration Number
- 3002993863
- FEI Number
- 3002993863
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No. 599 Wuxie Road, Shaoxing High-Tech Industrial Development Zone, No. 79 Zhongshan Road, Yuecheng District,
- City
- Shaoxing Zhejiang
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K250891
Owner / Operator
- Firm Name
- Shaoxing Fuqing Health Products Co., Ltd.
- Operator Number
- 10038000
- Address
- No. 599 Wuxie Road, Shaoxing High-Tech, Industrial Development Zone,
- City
- Shaoxing
- State
- Zhejiang
- Postal Code
- 312000
- Country
- CN
- Correspondent
- Dean Wu
US Agent
- Business Name
- Manton Business and Technology Services
- Contact Name
- Charles Shen
- Address
- 37 Winding Ridge
- City
- Oakland
- State
- NJ
- ZIP
- 07436
- Country
- US
- [email protected]
- Phone
- 608 2179358
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | FCM | Class 2 | Gastroenterology, Urology | No | 2025-06-11 |
Proprietary Names
CATHETER MALE POCKET16"STRTIP14KIT 30 US (M14UK)
CATHETER MALE HYDRPC16"STRTIP14KIT 30 US (HM14UK)
CATHETER MALE HYDRPC16"STRTIP12KIT 30 US (HM12UK)
CATHETER MALE HYDRPC16"STRTIP16KIT 30 US (HM16UK)
CATHETER INSERTION W/DISPOSAL BAG KIT US (K1)
CATHETER INSERTION W/UCONN KIT (90PK)US (K2-90)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)