Sun Island Enterprise Co., Ltd.
TaiwanFDA applicant, unverified
- Devices
- 1
What Sun Island Enterprise Co., Ltd. makes
Sun Island Enterprise Co., Ltd. manufactures sunglasses designed for general eye protection and UV radiation shielding.
The company’s products are classified as Class I medical devices under FDA regulations and are listed via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Sunglasses Ref K944398
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sun Island Enterprise Co., Ltd. have in the registry?
The registry currently lists 1 device for Sun Island Enterprise Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sun Island Enterprise Co., Ltd.'s devices?
Among its 1 most recently registered device, Sun Island Enterprise Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Sun Island Enterprise Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Sun Island Enterprise Co., Ltd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Sun Island Enterprise Co., Ltd. in the registry?
The most recently registered devices listed for Sun Island Enterprise Co., Ltd. include SUNGLASSES.