Xiamen Blue Star Enterprise Co., Ltd.
ChinaFDA applicant, unverified
- Devices
- 1
What Xiamen Blue Star Enterprise Co., Ltd. makes
Xiamen Blue Star Enterprise Co., Ltd. manufactures disposable surgical masks, designed for single-use in clinical and procedural settings to reduce infection risk.
These products are classified as Class II devices under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Disposable surgical mask Ref K220532
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Xiamen Blue Star Enterprise Co., Ltd. have in the registry?
The registry currently lists 1 device for Xiamen Blue Star Enterprise Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Xiamen Blue Star Enterprise Co., Ltd.'s devices?
Among its 1 most recently registered device, Xiamen Blue Star Enterprise Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Xiamen Blue Star Enterprise Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Xiamen Blue Star Enterprise Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Xiamen Blue Star Enterprise Co., Ltd. in the registry?
The most recently registered devices listed for Xiamen Blue Star Enterprise Co., Ltd. include Disposable surgical mask.