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CardioCare@Home Pro
EUDAMEDClass I (EU MDR)
Ref CardioCare@Home Pro
by Byteflies NV
Identity
- Trade Name
- CardioCare@Home Pro EUDAMED
- Model / Reference
- CardioCare@Home Pro EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05430001718195 EUDAMED
- Basic UDI-DI
- 5430001718BF10000451K8 EUDAMED
- Direct Marketing DI
- 05430001718195 EUDAMED
- EMDN Code
- Z12050392 ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Belgium 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
CardioCare@Home Pro by Byteflies NV — 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 | 5430001718BF10000451K8 | Class I | Active |
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Manufacturer
- Manufacturer
- Byteflies NV
- EUDAMED SRN
- BE-MF-000014680
Sources (1)
- EUDAMED c615ee00-d98b-4285-866e-75c451f34e7a 61 fields · synced Jul 9, 2026