Sun Wellen, Inc.
TaiwanFDA applicant, unverified FDA FEI 1000283119
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Sun Wellen, Inc. makes
Sun Wellen, Inc. manufactures sunglasses designed for UV protection and general eyewear use.
The company’s products fall under FDA Class I devices and are listed via the 510(k) pathway in the United States.
Catalogue
DeviceDevice · Authorizations Verified Status Regime Registry Class
Sunglasses Ref K942237
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 1000283119
- Address
- 137 FU HSING SOUTH RD.,, TAIPEI
Frequently asked questions
How many devices does Sun Wellen, Inc. have in the registry?
The registry currently lists 1 device for Sun Wellen, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sun Wellen, Inc.'s devices?
Among its 1 most recently registered device, Sun Wellen, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Sun Wellen, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Sun Wellen, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Sun Wellen, Inc. in the registry?
The most recently registered devices listed for Sun Wellen, Inc. include SUNGLASSES.