Data / Medical devices / Taiwan / Yomura Technologies Inc.
Yomura Technologies Inc.: FDA-registered device maker in New Taipei, Taiwan, 1 510(k) clearance
Yomura Technologies Inc. is registered with the FDA (registration 3006475220) in New Taipei, Taiwan. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 16, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006475220
- Address
- No. 2-3, Gong 8th Road Industrial Park II, Linkou District, New Taipei, Taiwan, 244
- Owner or operator
- Yomura Technologies Inc. (10048633)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- February 4, 2015
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Vein Location, Liquid Crystal | KZA | 1 | Contract manufacturer | accessdata.fda.gov |
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Contract manufacturer | accessdata.fda.gov |
| Stopcock, I.V. Set | FMG | 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 |
|---|---|---|---|---|---|---|
| May 16, 2022 | K210516 | Clicky Cross | FMG | Substantially Equivalent | Yomura Technologies, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Stopcock, I.V. Set
- All makers of Device, Vein Location, Liquid Crystal
- All makers of Lamp, Infrared, Therapeutic Heating
Updated May 16, 2022. 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.