Data / Medical devices / China / Anqing Mayfield Medical Limited
Anqing Mayfield Medical Limited: FDA-registered device maker in Anqing Anhui, China, 1 510(k) clearance
Anqing Mayfield Medical Limited is registered with the FDA (registration 3017421555) in Anqing Anhui, China. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 3, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017421555
- Address
- NO.15 Nansan road,Tongcheng Economic and Technological Development Zone, Anqing Anhui, China, 231400
- Owner or operator
- ANQING MAYFIELD MEDICAL LIMITED (10076152)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- July 9, 2020
- Registered through
- 2026
- Brand names listed
- Disposable Face Mask, Disposable diapers, Medical Disposable Face Masks, Protective Mask KN95
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | N | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Garment, Protective, For Incontinence | EYQ | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Respirator, Surgical | MSH | 2 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| January 3, 2023 | K222809 | Medical Disposable Face Masks | FXX | Substantially Equivalent | Anqing Mayfield Medical Limited | accessdata.fda.gov |
Compare with other makers
- All makers of Garment, Protective, For Incontinence
- All makers of Mask, Surgical
- All makers of Respirator, Surgical
- All makers of Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua
Updated January 3, 2023. 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.