FDA Registration
Active
🇨🇳 China
Jiangsu Suntec Medical Technology Co., Ltd.
Reg #: 3011475060
·
FEI: 3011475060
·
Expires 2026
Products
14
Proprietary Names
14
Establishment Types
2
Classifications
14
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Registration Details
- Registration Name
- Jiangsu Suntec Medical Technology Co., Ltd.
- Registration Number
- 3011475060
- FEI Number
- 3011475060
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Jiepai Industrial Zone
- City
- Jiepai Danyang Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K152878
Owner / Operator
- Firm Name
- Jiangsu Suntec Medical Technology Co., Ltd.
- Operator Number
- 10048106
- Address
- Jiepai Industrial Zone
- City
- Jiepai Danyang
- State
- Jiangsu
- Postal Code
- 212300
- Country
- CN
US Agent
- Business Name
- ROC Chinese-European Industrial Research Society
- Contact Name
- Shu-Chen Cheng
- Address
- 2064 Tamarin Dr
- City
- Columbus
- State
- OH
- ZIP
- 43235
- Country
- US
- [email protected]
- Phone
- 614 5888168
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Brake, Extension, Wheelchair | IMW | Class 1 | Physical Medicine | No | 2014-12-08 |
| Wheelchair, Mechanical | IOR | Class 1 | Physical Medicine | No | 2016-02-14 |
| Belt, Wheelchair | IQB | Class 1 | Physical Medicine | No | 2024-01-31 |
| Device, Anti-Tip, Wheelchair | IMR | Class 1 | Physical Medicine | No | 2014-12-08 |
| Chair, With Casters | INM | Class 1 | Physical Medicine | No | 2014-12-08 |
| Walker, Mechanical | ITJ | Class 1 | Physical Medicine | No | 2019-08-22 |
| Aid, Transfer | IKX | Class 1 | Physical Medicine | No | 2025-06-12 |
| Cart, Emergency, Cardiopulmonary (Excluding Equipment) | BZN | Class 1 | Anesthesiology | No | 2024-06-25 |
| Cushion, Wheelchair | IMP | Class 1 | Physical Medicine | No | 2014-12-08 |
| Attachment, Commode, Wheelchair | INB | Class 1 | Physical Medicine | No | 2014-12-08 |
| Accessories, Wheelchair | KNO | Class 1 | Physical Medicine | No | 2014-12-08 |
| Components, Wheelchair | KNN | Class 1 | Physical Medicine | No | 2014-12-08 |
| Adaptor, Hygiene | ILS | Class 1 | Physical Medicine | No | 2022-12-29 |
| Stand, Infusion | FOX | Class 1 | General Hospital | No | 2024-06-25 |
Proprietary Names
Wheelchair Extension Brake
SUNTEC Mechanical Wheelchair, model ST-WL-1000
Wheelchair Belt
Wheelchair Anti-Tip
Caster with Chair
Knee Walker, Walker, Rollator
Transfer Aid
Emergency Cart
Wheelchair Cushion
Commode
Wheelchair Accessories
Wheelchair Components
Bath Chair
Infusion Stand
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device