Breem Laboratories
Country not established
- Devices
- 1
What Breem Laboratories makes
Breem Laboratories manufactures hemodialysis concentrates and associated products designed to prepare solutions for renal replacement therapy, including electrolyte and acid-base balancing formulations.
These products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Hemodialysis Concentrates And Related Products Ref K860336
510(k) 510(k)
Frequently asked questions
How many devices does Breem Laboratories have in the registry?
The registry currently lists 1 device for Breem Laboratories. Devices recorded under merged duplicate company entries are counted once.
Which registries list Breem Laboratories's devices?
Among its 1 most recently registered device, Breem Laboratories has devices listed in FDA 510(k) (1 device).
What risk classes do Breem Laboratories's devices fall under?
Among its 1 most recently registered device, the classes recorded for Breem Laboratories's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Breem Laboratories in the registry?
The most recently registered devices listed for Breem Laboratories include HEMODIALYSIS CONCENTRATES AND RELATED PRODUCTS.