Taiwan Eva Industrial Co., Inc.
TaiwanFDA applicant, unverified
- Devices
- 3
What Taiwan Eva Industrial Co., Inc. makes
Taiwan Eva Industrial Co., Inc. manufactures non-prescription sunglasses, including photochromic lenses, as well as spectacle frames and eye shields designed for ophthalmic use. These products are intended for general eye protection and UV radiation filtering without requiring a prescription.
The company’s portfolio is classified under FDA’s Class I medical devices, which are subject to general controls and exempt from the 510(k) premarket notification requirement unless otherwise specified. These devices are listed with the FDA under the 510(k) pathway, though individual products may vary in regulatory status. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frame, Spectacles Ref K945350
Regimes: 510(k) Registry: 510(k)Shield, Eye, Ophthalmic Ref K945351
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Taiwan Eva Industrial Co., Inc. have in the registry?
The registry currently lists 3 devices for Taiwan Eva Industrial Co., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Taiwan Eva Industrial Co., Inc.'s devices?
Among its 3 most recently registered devices, Taiwan Eva Industrial Co., Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Taiwan Eva Industrial Co., Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Taiwan Eva Industrial Co., Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Taiwan Eva Industrial Co., Inc. in the registry?
The most recently registered devices listed for Taiwan Eva Industrial Co., Inc. include SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE), FRAME, SPECTACLES and SHIELD, EYE, OPHTHALMIC.