Hi-Shine Ent. Co., Ltd.
TaiwanFDA applicant, unverified
- Devices
- 1
What Hi-Shine Ent. Co., Ltd. makes
Hi-Shine Ent. Co., Ltd. manufactures sunglasses designed for general eye protection and UV radiation filtering.
The company’s products fall under FDA Class I devices and are listed via the 510(k) pathway in the United States.
Catalogue
Sunglasses Ref K940945
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Hi-Shine Ent. Co., Ltd. have in the registry?
The registry currently lists 1 device for Hi-Shine Ent. Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hi-Shine Ent. Co., Ltd.'s devices?
Among its 1 most recently registered device, Hi-Shine Ent. Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Hi-Shine Ent. Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Hi-Shine Ent. Co., Ltd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Hi-Shine Ent. Co., Ltd. in the registry?
The most recently registered devices listed for Hi-Shine Ent. Co., Ltd. include SUNGLASSES.