FDA Registration
Active
🇨🇳 China
GENTEC (SHANGHAI) CORPORATION
Reg #: 3005347827
·
FEI: 3005347827
·
Expires 2026
Products
12
Proprietary Names
12
Establishment Types
2
Classifications
12
Registration Details
- Registration Name
- GENTEC (SHANGHAI) CORPORATION
- Registration Number
- 3005347827
- FEI Number
- 3005347827
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- NO. 499 WENJI ROAD, SONGJIANG DISTRICT
- City
- SHANGHAI
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K142291
Owner / Operator
- Firm Name
- GENTEC (SHANGHAI) CORPORATION
- Operator Number
- 9077543
- Address
- NO.499 WENJI ROAD,, SONGJIANG DISTRICT
- City
- SHANGHAI
- State
- CN-NOTA
- Postal Code
- 201616
- Country
- CN
- Correspondent
- JAMES - KUO
US Agent
- Business Name
- GENSTAR TECHNOLOGIES CO., INC.
- Contact Name
- JIM TSO
- Address
- 4525 EDISON AVE.
- City
- CHINO
- State
- CA
- ZIP
- 91710
- Country
- US
- [email protected]
- Phone
- 909 6062726 ext. 113
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | Class 1 | Anesthesiology | No | 2020-03-30 |
| Regulator, Vacuum | KDP | Class 2 | General Hospital | No | 2005-09-14 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-03-20 |
| Mixer, Breathing Gases, Anesthesia Inhalation | BZR | Class 2 | Anesthesiology | No | 2016-12-08 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2025-03-20 |
| Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge | CCN | Class 1 | Anesthesiology | No | 2005-09-14 |
| Gauge, Gas Pressure, Cylinder/Pipeline | BXH | Class 1 | Anesthesiology | No | 2005-09-14 |
| Flowmeter, Tube, Thorpe, Back-Pressure Compensated | CAX | Class 1 | Anesthesiology | No | 2005-09-14 |
| Regulator, Pressure, Gas Cylinder | CAN | Class 1 | Anesthesiology | No | 2005-09-14 |
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 2005-09-14 |
| Yoke Assembly, Medical Gas | CAM | Class 1 | Anesthesiology | No | 2005-09-14 |
| Bottle, Collection, Vacuum | KDQ | Class 2 | General Hospital | No | 2020-06-15 |
Proprietary Names
Breathing Circuit
SUCTION REGULATOR; VACUUM REGULATOR
Face Mask
MEDICAL AIR/OXYGEN BLENDER
High Flow Nasal Cannula (HFNC)
FLOW GAUGE; NONBACK-PRESSURE COMPENSATED FLOWMETER
GAS PRESSURE GAUGE
BACK-PRESSURE COMPENSATED FLOWMETER
GENTEC GAS PRESSURE REGULATOR
DIAL FLOWMETER; MEDICAL HOSES; GAS OUTLET; MANIFOLDS SYSTEM; PIGTAILS, GAS ALARM; PIPELINE
GENETEC YOKE ASSEMBLY
VACUUM TRAP; SUCTION JAR
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device