CardioRenal Systems, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000035063 FEI 1287243
- Devices
- 2
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
- Authorised rep.
- RenalGuard Solutions EU GmbHDE
What CardioRenal Systems, Inc. makes
CardioRenal Systems, Inc. manufactures the RenalGuard Single Use Set, a disposable device for monitoring and managing renal function during procedures, and the RenalGuard Console, a reusable system for real-time assessment of kidney perfusion and fluid balance.
The company’s portfolio includes Class IIa and Class IIb medical devices, with products registered in the EU’s eudamed database. The manufacturer is based in the United States.
Catalogue
RenalGuard Single Use Set Ref AC00050
Regimes: CE MDD Registry: EUDAMEDRenalGuard Console Ref FM1
Regimes: CE MDD Registry: EUDAMED
Company details
- EUDAMED SRN
- US-MF-000035063
- FDA FEI number
- 1287243
- EU VAT number
- 04-274-5714
- EUDAMED status
- Active
- EUDAMED registered name
- CardioRenal Systems, Inc.
- Registered address
- 459, Fortune Blvd., 01757, Milford, United States
- Website
- renalguard.com
- [email protected]
- Phone
- 508-541-8800
- PRRC contact
- Richard Yeomans
Frequently asked questions
How many devices does CardioRenal Systems, Inc. have in the registry?
The registry currently lists 2 devices for CardioRenal Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list CardioRenal Systems, Inc.'s devices?
Among its 2 most recently registered devices, CardioRenal Systems, Inc. has devices listed in EUDAMED (2 devices).
What risk classes do CardioRenal Systems, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for CardioRenal Systems, Inc.'s devices are Class IIa and Class IIb. Each device page shows its own class and authorisation.
What are the newest devices from CardioRenal Systems, Inc. in the registry?
The most recently registered devices listed for CardioRenal Systems, Inc. include RenalGuard Single Use Set and RenalGuard Console.