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HeartX Management with inCareNet Dashboard
EUDAMEDClass I (EU MDR)
Ref 79313031Model HeartX Management with inCareNet Dashboard
Identity
- Trade Name
- HeartX Management with inCareNet Dashboard EUDAMED
- Device Name
- HeartX Management with inCareNet Dashboard EUDAMED
- Model / Reference
- HeartX Management with inCareNet Dashboard EUDAMED79313031 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250903202544 EUDAMED
- Basic UDI-DI
- 0425090320242N6 EUDAMED
- EMDN Code
- Z12050492 HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
HeartX Management with inCareNet Dashboard by Getemed Medizin- Und Informationstechnik Ag — 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 | 0425090320242N6 | Class I | Active |
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Manufacturer
- Manufacturer
- GETEMED Medizin- und Informationstechnik AG
- EUDAMED SRN
- DE-MF-000012384
Sources (1)
- EUDAMED bd701092-5c9f-4965-a252-7e796a027ef3 61 fields · synced Jul 22, 2026