FDA Registration
Active
🇨🇳 China
DANYANG XINYA VALVE CO., LTD.
Reg #: 3008281139
·
FEI: 3008281139
·
Expires 2026
Products
17
Proprietary Names
11
Establishment Types
4
Classifications
17
Registration Details
- Registration Name
- DANYANG XINYA VALVE CO., LTD.
- Registration Number
- 3008281139
- FEI Number
- 3008281139
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 12 Dongjin West Road, Yanling Town
- City
- Danyang Jiangsu
- Country
- CN
Owner / Operator
- Firm Name
- Danyang Xinya Valve Co., Ltd.
- Operator Number
- 10033907
- Address
- No. 12 Dongjin West Road, Yanling Town
- City
- Danyang Jiangsu
- State
- CN-JS
- Postal Code
- 212341
- Country
- CN
- Correspondent
- Xie Yi
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 |
|---|---|---|---|---|---|
| Airway, Oropharyngeal, Anesthesiology | CAE | Class 1 | Anesthesiology | No | 2023-11-13 |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | Class 1 | Anesthesiology | No | 2023-11-13 |
| Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge | CCN | Class 1 | Anesthesiology | No | 2012-05-07 |
| Flowmeter, Calibration, Gas | BXY | Class 1 | Anesthesiology | No | 2024-11-12 |
| Humidifier, Non-Direct Patient Interface (Home-Use) | KFZ | Class 1 | Anesthesiology | No | 2012-08-21 |
| Cart, Emergency, Cardiopulmonary (Excluding Equipment) | BZN | Class 1 | Anesthesiology | No | 2023-07-19 |
| Syringe, Ent | KCP | Class 1 | Ear, Nose, Throat | No | 2023-05-31 |
| Yoke Assembly, Medical Gas | CAM | Class 1 | Anesthesiology | No | 2021-03-01 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-05-18 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2014-08-29 |
| Connector, Airway (Extension) | BZA | Class 1 | Anesthesiology | No | 2023-05-31 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2023-05-31 |
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 2023-11-13 |
| Valve, Switching (Ploss) | JFE | Class 1 | Anesthesiology | No | 2024-08-01 |
| Flowmeter, Tube, Thorpe, Back-Pressure Compensated | CAX | Class 1 | Anesthesiology | No | 2012-05-07 |
| Cylinder, Compressed Gas, And Valve | ECX | Class 1 | Anesthesiology | No | 2024-05-10 |
| Regulator, Pressure, Gas Cylinder | CAN | Class 1 | Anesthesiology | No | 2010-10-18 |
Proprietary Names
Oropharyngeal Airway
CPAP tubing
FLOW METER for Oxygen Concentrator
Ear Syringe
Protective face mask, KN95 Protective Face Shield
Oxygen Connector
Oxygen Mask
Oxygen tubing
Switch, Pressure switch
M90 oxygen cylinder, M122 oxygen cylinder
Pilot valve, PE valve, M6 oxygen cylinder, M9 oxygen cylinder, D oxygen cylinder, E oxygen cylinder, M60 oxygen cylinder
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility