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HeartX Recorder ECG Patch "F"
EUDAMEDClass I (EU MDR)
Ref 86501Model HeartX Recorder ECG Patch
Identity
- Trade Name
- HeartX Recorder ECG Patch "F" EUDAMED
- Device Name
- HeartX Recorder ECG Patch EUDAMED
- Model / Reference
- HeartX Recorder ECG Patch EUDAMED86501 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250903203121 EUDAMED
- Basic UDI-DI
- 0425090320271ND EUDAMED
- EMDN Code
- C020501 ECG ELECTRODES EUDAMED
Classification
- Device Class
- Class I 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
Category: Electrocardiographic electrode, single-use
HeartX Recorder ECG Patch "F" by Getemed Medizin- Und Informationstechnik Ag — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Electrocardiographic electrode, single-use.
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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 | 0425090320271ND | Class I | Active |
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Manufacturer
- Manufacturer
- GETEMED Medizin- und Informationstechnik AG
- EUDAMED SRN
- DE-MF-000012384
Sources (1)
- EUDAMED a1c81c3b-a503-4886-a4c7-8abe5113f856 61 fields · synced Jun 19, 2026