Cardiacsense
Active in EUDAMEDIsraelfrom SRN EUDAMED SRN IL-MF-000014166
Part of CardiacSense Ltd.
- Devices
- 3
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
Catalogue
DeviceDevice · Authorizations Verified Status Regime Registry Class
CardiacSense Medical Watch Ref CS-FG0015BK
Regimes: CE MDR Registry: EUDAMEDCsf-3 Ref K221260
Regimes: 510(k) Registry: 510(k)CS System 4 Ref CS-FG0015BK
Regimes: CE MDR Registry: EUDAMED
Company details
- EUDAMED SRN
- IL-MF-000014166
- EUDAMED status
- Active
- EUDAMED registered name
- CardiacSense Ltd.
- EUDAMED abbreviated name
- Cardiacsense
- Registered address
- 6, Leshem St., 3079868, Caesarea, Israel
- Website
- www.cardiacsense.com
- [email protected]
- Phone
- +97247701726
- PRRC contact
- Assaf Gur
Frequently asked questions
How many devices does Cardiacsense have in the registry?
The registry currently lists 3 devices for Cardiacsense. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cardiacsense's devices?
Among its 3 most recently registered devices, Cardiacsense has devices listed in EUDAMED (2 devices) and FDA 510(k) (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Cardiacsense's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Cardiacsense's devices are Class IIa and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cardiacsense in the registry?
The most recently registered devices listed for Cardiacsense include CardiacSense Medical Watch, CSF-3 and CS System 4.