Shu Gie Industrial Co., Ltd.
TaiwanFDA applicant, unverified FDA FEI 1000202649
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Shu Gie Industrial Co., Ltd. makes
Shu Gie Industrial Co., Ltd. manufactures sunglasses designed for sports use and fishing, including protective eyewear for outdoor and aquatic activities.
These products are classified as Class I medical devices under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Sunlgasses, Sport Sunglasses & Fishing Glasses Ref K945735
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 1000202649
- Address
- ROOM NO.16, FL.5, NO.2, CHENG KUNG ROAD, TAINAN CITY
Frequently asked questions
How many devices does Shu Gie Industrial Co., Ltd. have in the registry?
The registry currently lists 1 device for Shu Gie Industrial Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Shu Gie Industrial Co., Ltd.'s devices?
Among its 1 most recently registered device, Shu Gie Industrial Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Shu Gie Industrial Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Shu Gie Industrial Co., Ltd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Shu Gie Industrial Co., Ltd. in the registry?
The most recently registered devices listed for Shu Gie Industrial Co., Ltd. include SUNLGASSES, SPORT SUNGLASSES & FISHING GLASSES.