Gentec (Shanghai) Corporation
Manufacturer and brand owner in Shanghai, China. 12 device types, 7 products catalogued, 1 clearance.
Gentec (Shanghai) Corporation is a manufacturer holding a current FDA establishment registration. The registration covers Regulator, Vacuum, Cannula, Nasal, Oxygen and 10 other device types. 7 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2005.
12device types registered with the FDA
7products catalogued under its own name
1510(k) clearance
Registration
| Registered name | GENTEC (SHANGHAI) CORPORATION |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3005347827 |
| FEI number | 3005347827 |
| DUNS | 545287658 |
| Establishment type | Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 捷锐企业（上海）有限公司 |
|---|---|
| Unified social credit code | 913100006072645397 |
| Source | NMPA UDI database |
Location
| City | Shanghai |
|---|---|
| Province | Shanghai |
| Address | NO. 499 WENJI ROAD |
| Postal code | 201616 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | Face Mask | 2020 | 439 |
| Bottle, Collection, Vacuum | Class 2 | Vacuum Trap; Suction JAR | 2020 | 88 |
| Cannula, Nasal, Oxygen | Class 1 | High Flow Nasal Cannula (HFNC) | 2025 | 97 |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | Class 1 | Breathing Circuit | 2020 | 55 |
| Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge | Class 1 | Flow Gauge; Nonback-Pressure Compensated Flowmeter | 2005 | 3 |
| Flowmeter, Tube, Thorpe, Back-Pressure Compensated | Class 1 | Back-Pressure Compensated Flowmeter | 2005 | 9 |
| Gauge, Gas Pressure, Cylinder/Pipeline | Class 1 | GAS Pressure Gauge | 2005 | 2 |
| Mixer, Breathing Gases, Anesthesia Inhalation | Class 2 | Medical AIR/Oxygen Blender | 2016 | 2 |
| Regulator, Pressure, Gas Cylinder | Class 1 | Gentec GAS Pressure Regulator | 2005 | 27 |
| Regulator, Vacuum | Class 2 | Suction Regulator; Vacuum Regulator | 2005 | 4 |
| Tubing, Pressure And Accessories | Class 1 | Dial Flowmeter; Medical Hoses; GAS Outlet; Manifolds System; Pigtails, GAS Alarm; Pipeline | 2005 | 45 |
| Yoke Assembly, Medical Gas | Class 1 | Genetec Yoke Assembly | 2005 | 3 |
Own-Brand Listings
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K142291 | 2015-05-19 | BZR | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1969 |
|---|---|
| Factory area | 50,000 square meters |
| Main products | Medical gas supply systems, Oxygen supply systems, Negative pressure treatment devices, Respiratory care products, Gas pressure reducers |
| Certifications | ISO 13485, CE, UL |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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