Shanghai Hua En Industrial Co Ltd
Registered establishment in Shanghai, China. 52 device types, 2 clearances.
Shanghai Hua En Industrial Co Ltd is a contract manufacturer holding a current FDA establishment registration. The registration covers Cotton, Roll, Cap, Surgical and 50 other device types. Its earliest product listing with the FDA dates from 2013.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3010147274 |
| FEI number | 3010147274 |
| Establishment type | Contract manufacturer, Specification developer, Repacker / relabeller, Private-label distributor, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 上海骅恩实业有限公司 |
|---|---|
| Source | Qichacha company register |
Location
| City | Shanghai |
|---|---|
| Province | Shanghai |
| Address | #30, NO988 HUI JI ROAD, XUANQIAO |
| Postal code | 201314 |
| Country | China |
What It Makes
Clearances
2 clearances name Shanghai Hua En Industrial Co Ltd as applicant. 5 are held by other companies 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 |
|---|---|---|---|---|
| K221838 | 2022-08-17 | FXX | Traditional | This company |
| K221222 | 2022-06-06 | FXX | Traditional | This company |
| K230061 | 2023-11-30 | FMF | Traditional | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. |
| K221875 | 2023-02-13 | FRG | Traditional | Qianjiang Kingphar Medical Packaging & Printing Co., Ltd. |
| K212578 | 2021-12-02 | LZA | Traditional | Xingyu Medical Tech Co., Ltd. |
| K211329 | 2021-11-15 | MEG | Traditional | Jiangsu Kangbao Medical Equipment Co., Ltd. |
| K211555 | 2021-10-18 | MEG | Traditional | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. |
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.