Data / Medical devices / Taiwan / Sigma Medical Supplies Corp.
Sigma Medical Supplies Corp.: FDA-registered device maker in Gueishan Taoyuan, Taiwan, 3 510(k) clearances
Sigma Medical Supplies Corp. is registered with the FDA (registration 3004970050) in Gueishan Taoyuan, Taiwan. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 23, 2021. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3004970050
- Address
- 29 Jianguo E.Rd., Gueishan Taoyuan, Taiwan, 33341
- Owner or operator
- SIGMA MEDICAL SUPPLIES CORP. (9026902)
- Roles
- Specification developer
- First device listed
- June 12, 2018
- Registered through
- 2026
- Brand names listed
- SIGMA Sterilization Pouch and Roll, SIGMA sterilization pouch and roll, Sterilization Pouch/Roll Made with Tyvek
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Indicator, Physical/Chemical Sterilization Process | JOJ | 2 | Specification developer | accessdata.fda.gov |
| Wrap, Sterilization | FRG | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| April 23, 2021 | K202462 | SIGMA Sterilization Pouch and Roll | FRG | Substantially Equivalent | Sigma Medical Supplies Corporation | accessdata.fda.gov |
| June 6, 2018 | K180672 | Sterilization Pouch/Roll Made with Tyvek | FRG | Substantially Equivalent | Sigma Medical Supplies Corporation | accessdata.fda.gov |
| June 5, 2018 | K180661 | SIGMA Sterilization Pouch and Roll | FRG | Substantially Equivalent | Sigma Medical Supplies Corp. | accessdata.fda.gov |
Compare with other makers
Updated April 23, 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.