FDA Registration
Active
🇨🇳 China
SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD.
Reg #: 3007361214
·
FEI: 3007361214
·
Expires 2026
Products
11
Proprietary Names
8
Establishment Types
2
Classifications
11
Registration Details
- Registration Name
- SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD.
- Registration Number
- 3007361214
- FEI Number
- 3007361214
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1/F, Zhongtianxin Building B, Longgang District,Shenzhen,Guangdong
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K133795
Owner / Operator
- Firm Name
- Sunny Medical Device (Shenzhen) Co., Ltd.
- Operator Number
- 10043316
- Address
- 1/F, Zhongtianxin Building B, Longgang District, Shenzhen, Guangdong
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518172
- Country
- CN
- Correspondent
- James Q Zhang
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Syringe, Balloon Inflation | MAV | Class 2 | Cardiovascular | No | 2015-08-18 |
| Wire, Guide, Catheter, Exempt | PTL | Class 2 | Cardiovascular | No | 2020-09-09 |
| Syringe, Balloon Inflation, Exempt | PTM | Class 2 | Cardiovascular | No | 2019-01-21 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-08-18 |
| Trocar | DRC | Class 2 | Cardiovascular | No | 2019-01-03 |
| Applier, Surgical, Clip | GDO | Class 1 | General, Plastic Surgery | No | 2020-04-06 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2016-11-03 |
| Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | DTL | Class 2 | Cardiovascular | No | 2016-11-03 |
| Injector And Syringe, Angiographic | DXT | Class 2 | Cardiovascular | No | 2016-12-13 |
| Clamp, Vascular | DXC | Class 2 | Cardiovascular | No | 2020-03-16 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2015-08-18 |
Proprietary Names
SunmedTM Inflation Device
SunmedTM guidewire torque device
SunmedTM Protective face shield
SunmedTM Manifold and Stopcocks
Sunmed
SunmedTM Control Syringes
AirTightTM Control Syringes
SunmedTM High Pressure Line
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)