G.E.M. Water Systems
Country not established
- Devices
- 3
What G.E.M. Water Systems makes
G.E.M. Water Systems manufactures dialyzer reprocessing systems and reverse osmosis systems designed for water purification in medical and industrial applications. These systems are used to prepare high-purity water for hemodialysis treatment and other processes requiring sterile, contaminant-free water.
The company’s portfolio is regulated under FDA’s Class II device classification, with devices authorised via the 510(k) pathway. Products are listed in the FDA’s 510(k) database. The manufacturer operates from the United States.
Catalogue
Dialyzer Reprocessing System Ref K944492
510(k) 510(k)G.E.M. Water Systems, International Ref K970674
510(k) 510(k)Reverse Osmosis System Ref K944493
510(k) 510(k)
Frequently asked questions
How many devices does G.E.M. Water Systems have in the registry?
The registry currently lists 3 devices for G.E.M. Water Systems. Devices recorded under merged duplicate company entries are counted once.
Which registries list G.E.M. Water Systems's devices?
Among its 3 most recently registered devices, G.E.M. Water Systems has devices listed in FDA 510(k) (3 devices).
What risk classes do G.E.M. Water Systems's devices fall under?
Among its 3 most recently registered devices, the classes recorded for G.E.M. Water Systems's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from G.E.M. Water Systems in the registry?
The most recently registered devices listed for G.E.M. Water Systems include DIALYZER REPROCESSING SYSTEM, G.E.M. WATER SYSTEMS, INTERNATIONAL and REVERSE OSMOSIS SYSTEM.