Data / Medical devices / China / Gentec (shanghai) Corporation
Gentec (shanghai) Corporation: FDA-registered device maker in Shanghai, China, 1 510(k) clearance
Gentec (shanghai) Corporation is registered with the FDA (registration 3005347827) in Shanghai, China. It lists 12 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 19, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005347827
- Address
- No. 499 Wenji Road Songjiang District, Shanghai, China, 201616
- Owner or operator
- GENTEC (SHANGHAI) CORPORATION (9077543)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- September 14, 2005
- Registered through
- 2026
- Brand names listed
- BACK-PRESSURE COMPENSATED FLOWMETER, Breathing Circuit, DIAL FLOWMETER; MEDICAL HOSES; GAS OUTLET; MANIFOLDS SYSTEM; PIGTAILS, GAS ALARM; PIPELINE, FLOW GAUGE; NONBACK-PRESSURE COMPENSATED FLOWMETER, Face Mask, GAS PRESSURE GAUGE, GENETEC YOKE ASSEMBLY, GENTEC GAS PRESSURE REGULATOR and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Exporter to the US | accessdata.fda.gov |
| Bottle, Collection, Vacuum | KDQ | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Cannula, Nasal, Oxygen | CAT | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | 1 | Manufacturer | accessdata.fda.gov |
| Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge | CCN | 1 | Manufacturer | accessdata.fda.gov |
| Flowmeter, Tube, Thorpe, Back-Pressure Compensated | CAX | 1 | Manufacturer | accessdata.fda.gov |
| Gauge, Gas Pressure, Cylinder/Pipeline | BXH | 1 | Manufacturer | accessdata.fda.gov |
| Mixer, Breathing Gases, Anesthesia Inhalation | BZR | 2 | Manufacturer | accessdata.fda.gov |
| Regulator, Pressure, Gas Cylinder | CAN | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Regulator, Vacuum | KDP | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Tubing, Pressure And Accessories | BYX | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Yoke Assembly, Medical Gas | CAM | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 19, 2015 | K142291 | GMX Series Medical Air/Oxygen Blender | BZR | Substantially Equivalent | Gentec (Shanghai) Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of Gauge, Gas Pressure, Cylinder/Pipeline
- All makers of Cannula, Nasal, Oxygen
- All makers of Circuit, Breathing (W Connector, Adaptor, Y Piece)
- All makers of Bottle, Collection, Vacuum
- All makers of Regulator, Vacuum
- All makers of Regulator, Pressure, Gas Cylinder
Updated May 19, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.