Is this your brand? Sign in to claim ownership.
Sign in to claim this brandEarlysense, Ltd.
US
Last updated May 25, 2026
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 649822657
Catalogue (20)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| EarlySense® InSight™ | N/A | FDA UDI | Class II | Active |
| EarlySense® InSight™ | Insight at Home | FDA UDI | Class II | Active |
| EarlySense® Chair Sensor | N/A | FDA UDI | Class II | Active |
| Hill-Rom® Heart and Respiration Rate Monitoring System powered by EarlySense® | AME-00202 HR US | FDA UDI | Class II | Active |
| EarlySense® BEX Sensor | AME-01610 US | FDA UDI | Class II | Active |
| EarlySense® Bedside Unit | N/A | FDA UDI | Class II | Active |
| EarlySense® Contact-Free Sensor | N/A | FDA UDI | Class II | Active |
| EarlySense® Central Display Unit | N/A | FDA UDI | Class II | Active |
| Everon | K082465 | FDA 510(k) | Class II | Active |
| Earlysense Central Display System | K121885 | FDA 510(k) | Class II | Active |
| Everon 1.0 | K092062 | FDA 510(k) | Class II | Active |
| Chair Sensing Unit For Earlysense System | K133661 | FDA 510(k) | Class II | Active |
| Everon Central Display Station - Cds, Model Version 1.0.0 | K100376 | FDA 510(k) | Class II | Active |
| Everon Central Display Station (cds) | K110521 | FDA 510(k) | Class II | Active |
| EarlySense Central Display Station (CDS) | K151006 | FDA 510(k) | Class II | Active |
| Earlysense Es-16 System | K070375 | FDA 510(k) | Class II | Active |
| Earlysense | K131379 | FDA 510(k) | Class II | Active |
| Earlysense (everon) System | K120465 | FDA 510(k) | Class II | Active |
| EarlySense Insight Sytem | K152911 | FDA 510(k) | Class II | Active |
| EarlySense Bed Sensing Unit | K171836 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.