Data / Medical devices / China / Wuhan Huaxin Nonwoven Co., Ltd
Wuhan Huaxin Nonwoven Co., Ltd: FDA-registered device maker in Wuhan Hubei, China, 3 510(k) clearances
Wuhan Huaxin Nonwoven Co., Ltd is registered with the FDA (registration 3013006775) in Wuhan Hubei, China. It lists 13 device types. The FDA files 3 510(k) clearances under its listings, the newest dated March 8, 2022. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3013006775
- Address
- Special No.2, Wanling Village, Yong An Street Caidian District, Wuhan City, Hubei Province, Wuhan Hubei, China, 430000
- Owner or operator
- WUHAN DYMEX HEALTHCARE CO., LTD. (10050831)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- December 31, 2015
- Registered through
- 2026
- Brand names listed
- BEDDING, DISPOSABLE, MEDICAL, Bouffant cap, C-Arm Surgical Drape Cover, COVER, SHOE, OPERATING-ROOM, DRESS, SURGICAL, Disposable Sterile Radiation Protection Drape, Drape, surgical, GOWN, EXAMINATION and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Manufacturer | accessdata.fda.gov |
| Bedding, Disposable, Medical | KME | 1 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Cap, Surgical | FYF | 1 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Cover, Shoe, Operating-Room | FXP | 1 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Drape, Surgical, Antimicrobial | KKX | 2 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Drape, Surgical, Exempt | PUI | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Dress, Surgical | FYE | 1 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Gown, Examination | FME | 1 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Manufacturer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Manufacturer | accessdata.fda.gov |
| Pad, Kelly | FNW | 2 | Manufacturer | accessdata.fda.gov |
| Shoe And Shoe Cover, Conductive | BWP | 1 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Suit, Surgical | FXO | 1 | Contract manufacturer, Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| March 8, 2022 | K214087 | Medical Face Mask | FXX | Substantially Equivalent | Hubei Medlink Healthcare Co., Ltd. | accessdata.fda.gov |
| June 7, 2021 | K210433 | Surgical Face Mask (Ear loops and Tie-on) | FXX | Substantially Equivalent | Wuhan Dymex Healthcare Co., Ltd. | accessdata.fda.gov |
| May 27, 2019 | K182515 | Surgical Face Mask | FXX | Substantially Equivalent | Wuhan Dymex Healthcare Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Gown, Examination
- All makers of Pad, Kelly
- All makers of Mask, Surgical
- All makers of Suit, Surgical
- All makers of Non-Surgical Gown
- All makers of Drape, Surgical, Exempt
Updated March 8, 2022. 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.