Data / Medical devices / Hong Kong / Skypro Medical Supplies Company
Skypro Medical Supplies Company: FDA-registered device maker in Hong Kong, Hong Kong, 2 510(k) clearances
Skypro Medical Supplies Company is registered with the FDA (registration 3008191254) in Hong Kong, Hong Kong. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 24, 2021. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3008191254
- Address
- Room C301-303, Tsing Yi Industrial Ctr Tsing Yi, Hong Kong, Hong Kong, 990777
- Owner or operator
- Skypro Medical Supplies Company (10031131)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- June 2, 2017
- Registered through
- 2026
- Brand names listed
- Surgical Gown, Surgical Mask
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Gown, Surgical | FYA | 2 | Contract manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | 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 |
|---|---|---|---|---|---|---|
| December 24, 2021 | K202255 | Skypro, SP02 Mask (3) | FXX | Substantially Equivalent | Skypro Medical Supplies Company | accessdata.fda.gov |
| August 26, 2016 | K152197 | Skypro, SP01 Mask | FXX | Substantially Equivalent | Skypro Medical Supplies Company | accessdata.fda.gov |
Compare with other makers
Updated December 24, 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.