Wuhan Huaxin Nonwoven Co., Ltd.
Registered establishment in Wuhan, Hubei, China. 13 device types.
Wuhan Huaxin Nonwoven Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Pad, Kelly, Cap, Surgical and 11 other device types. Its earliest product listing with the FDA dates from 2015.
Registration
| Registered name | WUHAN HUAXIN NONWOVEN CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3013006775 |
| FEI number | 3013006775 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 武汉华鑫无纺布有限公司 |
|---|---|
| Source | Qichacha company register |
Location
| City | Wuhan |
|---|---|
| Province | Hubei |
| Address | Special No.2, Wanling Village, Yong An Street |
| Postal code | 430000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | Lab coat, Lab jacket | 2015 | 439 |
| Bedding, Disposable, Medical | Class 1 | Bedding, Disposable, Medical | 2016 | 308 |
| Cap, Surgical | Class 1 | Bouffant cap | 2015 | 178 |
| Cover, Shoe, Operating-Room | Class 1 | Cover, Shoe, Operating-Room | 2016 | 176 |
| Drape, Surgical, Antimicrobial | Class 2 | Drape, surgical | 2016 | 39 |
| Drape, Surgical, Exempt | Class 2 | Sterile CT Surgical Drape | 2026 | 107 |
| Dress, Surgical | Class 1 | Dress, Surgical | 2016 | 71 |
| Gown, Examination | Class 1 | Gown, Examination | 2016 | 109 |
| Mask, Surgical | Class 2 | Surgical Face Mask( Ear Loops and Tie-on), Medical Face Mask, Surgical Face Mask | 2019 | 125 |
| Non-Surgical Gown | Class 1 | Isolation gown | 2015 | 318 |
| Pad, Kelly | Class 2 | Disposable Sterile Radiation Protection Drape | 2024 | 5 |
| Shoe And Shoe Cover, Conductive | Class 1 | Shoe cover | 2015 | 32 |
| Suit, Surgical | Class 1 | Patient gown, Scrub suit | 2015 | 74 |
Clearances
No clearance names Wuhan Huaxin Nonwoven Co., Ltd. as applicant. 3 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 |
|---|---|---|---|---|
| K214087 | 2022-03-08 | FXX | Traditional | Hubei Medlink Healthcare Co., Ltd. |
| K210433 | 2021-06-07 | FXX | Traditional | Wuhan Dymex Healthcare Co., Ltd. |
| K182515 | 2019-05-27 | FXX | Traditional | Wuhan Dymex Healthcare Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2004 |
|---|---|
| Employees | 500+ |
| Factory area | 80000 |
| Main products | surgical masks, PPE, coveralls, surgical gowns, surgical dressings |
| Export markets | global |
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.