Data / Medical devices / China / U-Play Products Corporation
U-Play Products Corporation: FDA-registered device maker in wuhu Anhui, China, 1 510(k) clearance
U-Play Products Corporation is registered with the FDA (registration 3014142845) in wuhu Anhui, China. It lists 10 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 4, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014142845
- Address
- 7 Fumin Road, Wuhu Area of China (Anhui) Pilot Free Trade Zone, wuhu Anhui, China, 241000
- Owner or operator
- U-PLAY PRODUCTS CORPORATION (10056213)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- November 16, 2017
- Registered through
- 2026
- Brand names listed
- Cotton pad, Coverall, Diaper, Pull-up Diaper, Soft tissue, Soft Facial Tissue; Disposable bath towel; Multi-purpose towel, Disposable Medical Mask, Face Mask, Face Mask, Isolation Mask, Isolation Mask, Under pad and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Disinfectant, Medical Devices | LRJ | 1 | Exporter to the US, 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 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Fiber, Medical, Absorbent | FRL | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Garment, Protective, For Incontinence | EYQ | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Mask, Scavenging | KHA | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68) | NTX | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Suit, Surgical | FXO | 1 | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| March 4, 2021 | K202137 | Disposable medical mask | FXX | Substantially Equivalent | U-Play Products Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of Suit, Surgical
- All makers of Accessory, Surgical Apparel
- All makers of Mask, Surgical
- All makers of Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua
- All makers of Fiber, Medical, Absorbent
- All makers of Disinfectant, Medical Devices
Updated March 4, 2021. 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.