Data / Medical devices / China / Hubei Deming Healthcare Products Co.,ltd.
Hubei Deming Healthcare Products Co.,ltd.: FDA-registered device maker in Xiantao Hubei, China, 1 510(k) clearance
Hubei Deming Healthcare Products Co.,ltd. is registered with the FDA (registration 3008311433) in Xiantao Hubei, China. It lists 9 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 27, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008311433
- Address
- No.18, Liukou Industrial Park, west side of Xianpeng Road, Green Bay Community, Shazui Street, Xiantao Hubei, China, 433018
- Owner or operator
- HUBEI DEMING HEALTHCARE PRODUCTS CO.,LTD. (10044891)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- August 15, 2013
- Registered through
- 2026
- Brand names listed
- ACCESSORY,SURGICAL APPAREL, BEDDING,DISPASABLE,MEDICAL, CAP,SURGICAL, CHU TIAN DE MING Single use surgical mask, Face mask, Non-surgical isolation gown, Patient exam gown, Surgical Face Mask and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Bedding, Disposable, Medical | KME | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Cap, Surgical | FYF | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Cover, Shoe, Operating-Room | FXP | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | N | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Gown, Examination | FME | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Mask, Scavenging | KHA | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Manufacturer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| 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 Mask, Surgical
- All makers of Bedding, Disposable, Medical
- All makers of Cap, Surgical
- All makers of Mask, Scavenging
- All makers of Cover, Shoe, Operating-Room
- All makers of Gown, Examination
Updated May 27, 2019. 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.