Shanghai Gaohui Rubber AND Plastic Products Co., Ltd.
Registered establishment in Shanghai, China. 5 device types.
Shanghai Gaohui Rubber AND Plastic Products Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Blood Pressure Cuff, Orthosis, Limb Brace and 3 other device types. Its earliest product listing with the FDA dates from 2018.
Registration
| Registered name | SHANGHAI GAOHUI RUBBER AND PLASTIC PRODUCTS CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3008381116 |
| FEI number | 3008381116 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Location
| City | Shanghai |
|---|---|
| Province | Shanghai |
| Address | No. 6 Lane 381 Hongan Rd. |
| Postal code | 201503 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Blood Pressure Cuff | Class 2 | Blood Pressure Cuff | 2021 | 50 |
| Infusor, Pressure, For I.V. Bags | Class 1 | Pressure Infuser | 2018 | 25 |
| Orthosis, Limb Brace | Class 1 | dvt sleeve, Calf thigh DVT | 2023 | 144 |
| Strap, Head, Gas Mask | Class 1 | Hook&Loop Strap, 1″ WideX36″ Long-White Strap | 2024 | 29 |
| Tourniquet, Pneumatic | Class 1 | Tourniquet | 2024 | 21 |
Clearances
No clearance names Shanghai Gaohui Rubber AND Plastic Products Co., Ltd. as applicant. One is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K140874 | 2014-09-02 | DXQ | Traditional | Shanghai Goahui Rubber and Plastic Company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2001 |
|---|---|
| Employees | 80 |
| Main products | Blood pressure cuffs, Monitor cuffs, Tourniquets, PVC tubes, TPU tubes |
| Certifications | ISO 13485, FDA 510K |
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.
The manufacturer named here can complete this record.