C.G.H. Medical, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 11
What C.G.H. Medical, Inc. makes
C.G.H. Medical, Inc. manufactures hemodialysis devices, including dialyzers, filters, and associated kits such as the Gambro Bicart 720G, CentrySystem 3 with BP monitoring, and Lundia Alpha hemodialyzers. Their portfolio includes standalone dialyzers like the COBE CentrySystem CS500 and bundled systems like the Hemospal Kit B22 with Multiflow 60. Additional products include the Gambro Engstrom Y-filter packages and the Filtral hemodialyzers, designed for renal treatment procedures.
The company’s devices are classified under FDA’s Class I and Class II categories, with regulatory records supported by 510(k) clearances. These products are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. medical device regulations. The manufacturer operates from the United States.
Catalogue
Search and filter all 11 devicesFrequently asked questions
How many devices does C.G.H. Medical, Inc. have in the registry?
The registry currently lists 11 devices for C.G.H. Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list C.G.H. Medical, Inc.'s devices?
Among its 11 most recently registered devices, C.G.H. Medical, Inc. has devices listed in FDA 510(k) (11 devices).
What risk classes do C.G.H. Medical, Inc.'s devices fall under?
Among its 11 most recently registered devices, the classes recorded for C.G.H. Medical, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from C.G.H. Medical, Inc. in the registry?
The most recently registered devices listed for C.G.H. Medical, Inc. include GAMBRO BICART 720G, CENTRYSYSTEM 3 WITH CHARTS/BP OPTION, HEMOSPAL KIT B22 and COBE CENTRYSYSTEM CS500 DIALYZER.