HeartX Recorder ECG Patch "M"

EUDAMED

Class I (EU MDR)

Ref 86502Model HeartX Recorder ECG Patch

by GETEMED Medizin- und Informationstechnik AG

Identity

Trade Name: HeartX Recorder ECG Patch "M" EUDAMED
Device Name: HeartX Recorder ECG Patch EUDAMED
Model / Reference: HeartX Recorder ECG Patch EUDAMED
86502 EUDAMED

Identifiers

Primary DI / UDI-DI: 04250903203138 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

EUDAMED

Implantable

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Category: Electrocardiographic electrode, single-use

HeartX Recorder ECG Patch "M" 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 3e528e16-aa3f-4653-9df6-72b68127aa82 61 fields · synced Jun 18, 2026