Identity
- Trade Name
- HeartX EUDAMED
- Device Name
- HeartX Recorder EUDAMED
- Model / Reference
- HeartX Recorder EUDAMED86100; 86100-IEM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250903203039 EUDAMED
- Basic UDI-DI
- 0425090320274NK EUDAMED
- EMDN Code
- Z12050403 ECG HOLTER RECORDERS EUDAMED
Classification
- Device Class
- Class IIa 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 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 | 0425090320274NK | Class IIa | Active |
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Manufacturer
- Manufacturer
- GETEMED Medizin- und Informationstechnik AG
- EUDAMED SRN
- DE-MF-000012384
Sources (2)
- EUDAMED 57fcbbc4-6ab9-477d-890a-7ddb349747ce 61 fields · synced Jun 18, 2026
- EUDAMED 57fcbbc4-6ab9-477d-890a-7ddb349747ce-1 61 fields · synced Jun 10, 2026