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myCordella System Pack - English
EUDAMEDClass I (EU MDR)
Ref 100366-00Model myCordella System Pack
Identity
- Trade Name
- myCordella System Pack - English EUDAMED
- Device Name
- myCordella Patient Kit EUDAMED
- Model / Reference
- myCordella System Pack EUDAMED100366-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850008997075 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
myCordella System Pack - English 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, Inc.
- EUDAMED SRN
- US-PR-000023160
Sources (1)
- EUDAMED 04728e65-b3a6-4421-bba8-4dddb6006ac3 61 fields · synced Oct 6, 2026