Cobe Renal Care, Inc.
United StatesFDA applicant, unverified
- Devices
- 14
What Cobe Renal Care, Inc. makes
Cobe Renal Care manufactures hemodialysis devices, including the Gambro Lundia 94-700, Sigma 800, and CentrySystem 600 HG hemodialyzers, as well as dialyzers like the Lundia 94-500 and CentrySystem CS 200. The company also produces hemofilters such as the Gambro FH 66D and FH 22H, along with specialized systems like the Prisma CFM for continuous fluid management and the Gambro HC 14R hemoconcentrator. Monitoring solutions include the Cobe Hemodynamic Recirculation Monitor, and additional hemodialyzers like the Polyflux series and CentrySystem 14 PES.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The company’s products are listed in the FDA’s 510(k) database, reflecting their regulatory authorization for use in renal therapies. Cobe Renal Care, Inc. is based in the United States.
Catalogue
Search and filter all 14 devicesFrequently asked questions
How many devices does Cobe Renal Care, Inc. have in the registry?
The registry currently lists 14 devices for Cobe Renal Care, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cobe Renal Care, Inc.'s devices?
Among its 14 most recently registered devices, Cobe Renal Care, Inc. has devices listed in FDA 510(k) (14 devices).
What risk classes do Cobe Renal Care, Inc.'s devices fall under?
Among its 14 most recently registered devices, the classes recorded for Cobe Renal Care, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cobe Renal Care, Inc. in the registry?
The most recently registered devices listed for Cobe Renal Care, Inc. include GAMBRO LUNDIA 94-700 & SIGMA 800 HEMODIALYZERS, COBE CENTRYSYSTEM 600 HG HEMODIALYZERS, GAMBRO LUNDIA 94-500 DIALYZER and GAMBRO FH 66 D HEMOFILTER.