Data / Medical devices / China / Shanghai Gaohui Rubber And Plastic Products Co., Ltd
Shanghai Gaohui Rubber And Plastic Products Co., Ltd: FDA-registered device maker in Shanghai, China, 1 510(k) clearance
Shanghai Gaohui Rubber And Plastic Products Co., Ltd is registered with the FDA (registration 3008381116) in Shanghai, China. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 2, 2014. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3008381116
- Address
- No. 6 Lane 381 Hongan Rd. Zhujingzhen, Jinshan District, Shanghai, China, 201503
- Owner or operator
- SHANGHAI GAOHUI RUBBER AND PLASTIC PRODUCTS CO., LTD (10032286)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- December 21, 2018
- Registered through
- 2026
- Brand names listed
- 1" WideX36" Long-White Strap, Blood Pressure Cuff, Calf thigh DVT, Hook&Loop Strap, Pressure Infuser, Tourniquet, dvt sleeve
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Blood Pressure Cuff | DXQ | 2 | Manufacturer | accessdata.fda.gov |
| Infusor, Pressure, For I.V. Bags | KZD | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Orthosis, Limb Brace | IQI | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Strap, Head, Gas Mask | BTK | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Tourniquet, Pneumatic | KCY | 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 |
|---|---|---|---|---|---|---|
| September 2, 2014 | K140874 | GH DISPOSABLE AND GH REUSABLE BLOOD PRESSURE CUFF | DXQ | Substantially Equivalent | Shanghai Goahui Rubber and Plastic Company | accessdata.fda.gov |
Compare with other makers
- All makers of Orthosis, Limb Brace
- All makers of Blood Pressure Cuff
- All makers of Tourniquet, Pneumatic
- All makers of Strap, Head, Gas Mask
- All makers of Infusor, Pressure, For I.V. Bags
Updated September 2, 2014. 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.