Identity
- Trade Name
- HeartX Viewer EUDAMED
- Device Name
- HeartX Viewer EUDAMED
- Model / Reference
- HeartX Viewer EUDAMED79313011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250903202483 EUDAMED
- Basic UDI-DI
- 0425090320241N4 EUDAMED
- EMDN Code
- Z12050492 HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
HeartX Viewer by Getemed Medizin- Und Informationstechnik Ag — Class IIa — 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 | 0425090320241N4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- GETEMED Medizin- und Informationstechnik AG
- EUDAMED SRN
- DE-MF-000012384
Sources (1)
- EUDAMED 8225f3fe-47c8-4ee4-bea0-572535334aff 61 fields · synced Jun 19, 2026