Data / Medical devices / Taiwan / Eva Optiks, Inc.
Eva Optiks, Inc.: FDA-registered device maker in Kaohsiung, Taiwan, 1 510(k) clearance
Eva Optiks, Inc. is registered with the FDA (registration 9680236) in Kaohsiung, Taiwan. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 12, 1994. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9680236
- FEI number
- 3002686669
- Address
- 7F, No. 30 Chung Cheng 2ND RD., Kaohsiung, Taiwan, --
- Owner or operator
- EVA OPTIKS, INC. (9007408)
- Roles
- Manufacturer
- First device listed
- October 25, 2001
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | 1 | Manufacturer | accessdata.fda.gov |
| Spectacle, Magnifying | HOI | 1 | Manufacturer | accessdata.fda.gov |
| Sunglasses (Non-Prescription Including Photosensitive) | HQY | 1 | 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 |
|---|---|---|---|---|---|---|
| July 12, 1994 | K941047 | WESTERN TRADING CO | HQY | Substantially Equivalent | Eva Optiks, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Sunglasses (Non-Prescription Including Photosensitive)
- All makers of Spectacle, Magnifying
- All makers of Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
Updated July 12, 1994. 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.