FDA Registration
Active
🇨🇳 China
NINGBO SHENYU MEDICAL EQUIPMENT CO., LTD.
Reg #: 3010461764
·
FEI: 3010461764
·
Expires 2026
Products
9
Proprietary Names
12
Establishment Types
3
Classifications
9
Registration Details
- Registration Name
- NINGBO SHENYU MEDICAL EQUIPMENT CO., LTD.
- Registration Number
- 3010461764
- FEI Number
- 3010461764
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- West of Tanjialing Road
- City
- Yuyao Zhejiang
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K231110
Owner / Operator
- Firm Name
- Ningbo Shenyu Medical Equipment Co., Ltd.
- Operator Number
- 10045006
- Address
- West of Tanjialing Road
- City
- Yuyao
- State
- Zhejiang
- Postal Code
- 315408
- Country
- CN
- Correspondent
- Yonghui Rong
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 |
|---|---|---|---|---|---|
| Table, Mechanical | INW | Class 1 | Physical Medicine | No | 2015-02-11 |
| Crutch | IPR | Class 1 | Physical Medicine | No | 2013-09-11 |
| Wheelchair, Mechanical | IOR | Class 1 | Physical Medicine | No | 2023-07-09 |
| Chair, Adjustable, Mechanical | INN | Class 1 | Physical Medicine | No | 2013-09-11 |
| Wheelchair, Powered | ITI | Class 2 | Physical Medicine | No | 2026-03-25 |
| Chair, With Casters | INM | Class 1 | Physical Medicine | No | 2013-09-11 |
| Cane, Safety Walk | KHY | Class 1 | Physical Medicine | No | 2013-09-11 |
| Walker, Mechanical | ITJ | Class 1 | Physical Medicine | No | 2013-09-11 |
| Adaptor, Hygiene | ILS | Class 1 | Physical Medicine | No | 2013-12-25 |
Proprietary Names
Table, Mechanical Table
Crutches
Manual Wheelchair (A006)
Wheel chairs
Electric Wheelchair (W-A807, W-A807L)
Transport Chairs
Manual Wheelchair
Canes
Walkers, Rollators
Manual Wheelchair (SYIV100A008)
Shower chair; Raised Toilet Seat; Commode Chairs
Safety Rail; Bathtub safety rail; Toilet safety rail;Bed safety rail
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device