Avalon Biomedical (Shenzhen) Limited
ChinaFDA 510(k) applicant, unverified
- Devices
- 1
What Avalon Biomedical (Shenzhen) Limited makes
Avalon Biomedical (Shenzhen) Limited manufactures neonatal phototherapy systems designed to treat jaundice in newborns by using specific wavelengths of light to break down excess bilirubin in the bloodstream.
The company’s devices are classified as Class II under regulatory frameworks and are listed via the FDA’s 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Neonatal Phototherapy System Ref K200031
510(k) 510(k)
Frequently asked questions
How many devices does Avalon Biomedical (Shenzhen) Limited have in the registry?
The registry currently lists 1 device for Avalon Biomedical (Shenzhen) Limited. Devices recorded under merged duplicate company entries are counted once.
Which registries list Avalon Biomedical (Shenzhen) Limited's devices?
Among its 1 most recently registered device, Avalon Biomedical (Shenzhen) Limited has devices listed in FDA 510(k) (1 device).
What risk classes do Avalon Biomedical (Shenzhen) Limited's devices fall under?
Among its 1 most recently registered device, the classes recorded for Avalon Biomedical (Shenzhen) Limited's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Avalon Biomedical (Shenzhen) Limited in the registry?
The most recently registered devices listed for Avalon Biomedical (Shenzhen) Limited include Neonatal Phototherapy System.