U-Top Enterprise Co., Ltd.
TaiwanFDA 510(k) applicant, unverified
- Devices
- 1
What U-Top Enterprise Co., Ltd. makes
U-Top Enterprise Co., Ltd. manufactures spectacle frames and sunglasses designed for optical and protective eyewear applications. These products are intended for general use, including prescription and non-prescription eyewear, with a focus on durability and style.
The company’s portfolio is classified under FDA’s Class I medical devices, which typically require the least regulatory oversight. These devices are listed via the FDA’s 510(k) pathway, indicating they meet applicable regulatory standards for safety and performance. The company operates from the United States.
Catalogue
- 510(k) 510(k)
Frequently asked questions
How many devices does U-Top Enterprise Co., Ltd. have in the registry?
The registry currently lists 1 device for U-Top Enterprise Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list U-Top Enterprise Co., Ltd.'s devices?
Among its 1 most recently registered device, U-Top Enterprise Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do U-Top Enterprise Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for U-Top Enterprise Co., Ltd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from U-Top Enterprise Co., Ltd. in the registry?
The most recently registered devices listed for U-Top Enterprise Co., Ltd. include U-TOP ENTERPRISE CO SPECTACLE FRAMES & SUNGLASSES.