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Cordella Heart Failure System
EUDAMEDClass I (EU MDR)
Ref 100366-01Model Cordella Heart Failure SystemModel myCordella System Pack
by Endotronix
Identity
- Trade Name
- Cordella Heart Failure System EUDAMEDmyCordella System Pack - Dutch EUDAMED
- Device Name
- Cordella Heart Failure System EUDAMEDmyCordella Patient Kit EUDAMED
- Model / Reference
- Cordella Heart Failure System EUDAMED100366-01 EUDAMEDmyCordella System Pack EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850008997082 EUDAMED
- Basic UDI-DI
- 0850008997CHFSXT EUDAMED
- EMDN Code
- Z12039099 VARIOUS INSTRUMENTS TO SUPPORT AND MONITOR VITAL SIGNS – OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Medical Purpose
- The Cordella Heart Failure System is intended to electronically transfer communications and data from a set of medical devices in a heart failure patient’s home to a database for storage, retrieval and display to healthcare providers. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Cordella Heart Failure System by Endotronix, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0850008997CHFSXT | Class I | Active |
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Manufacturer
- Manufacturer
- Endotronix
- EUDAMED SRN
- US-PR-000023160
Sources (2)
- EUDAMED 5a87f59d-8891-4526-a892-9c0691303000 61 fields · synced Jun 20, 2026
- EUDAMED b828f0ca-2618-495a-b7b2-03177926033e 61 fields · synced Jun 20, 2026