Renal Hygienics
Country not established
- Devices
- 1
What Renal Hygienics makes
Renal Hygienics produces hemodialysis concentrate formulations and additives designed for use in renal replacement therapy. These products are intended to be mixed with water to create dialysate solutions for hemodialysis procedures, supporting the removal of waste and excess fluids from patients with kidney failure.
The company’s portfolio is regulated under FDA’s Class II device classification, with individual products authorised via the 510(k) pathway. These products are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Hemodialysis Concentrate Formulations/Additives Ref K860297
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Renal Hygienics have in the registry?
The registry currently lists 1 device for Renal Hygienics. Devices recorded under merged duplicate company entries are counted once.
Which registries list Renal Hygienics's devices?
Among its 1 most recently registered device, Renal Hygienics has devices listed in FDA 510(k) (1 device).
What risk classes do Renal Hygienics's devices fall under?
Among its 1 most recently registered device, the classes recorded for Renal Hygienics's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Renal Hygienics in the registry?
The most recently registered devices listed for Renal Hygienics include HEMODIALYSIS CONCENTRATE FORMULATIONS/ADDITIVES.