Royal Flash Enterprise Co., Ltd.
TaiwanFDA applicant, unverified
- Devices
- 1
What Royal Flash Enterprise Co., Ltd. makes
Royal Flash Enterprise Co., Ltd. manufactures the Royal Flash, a Class I medical device designed for use in specific diagnostic or procedural applications (device category unspecified).
The Royal Flash is regulated under the FDA’s 510(k) pathway as a Class I device and is listed in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
Royal Flash Ref K952939
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Royal Flash Enterprise Co., Ltd. have in the registry?
The registry currently lists 1 device for Royal Flash Enterprise Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Royal Flash Enterprise Co., Ltd.'s devices?
Among its 1 most recently registered device, Royal Flash Enterprise Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Royal Flash Enterprise Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Royal Flash Enterprise Co., Ltd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Royal Flash Enterprise Co., Ltd. in the registry?
The most recently registered devices listed for Royal Flash Enterprise Co., Ltd. include ROYAL FLASH.