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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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HeartX Recorder ECG Patch — 2 UDI-DI variants, MDR

MD Atlas
GETEMED Medizin- und Informationstechnik AG

Data from EUDAMED, last updated May 23, 2026

HeartX Recorder ECG Patch

0425090320271ND

2 UDI-DI variants

MDR [Regulation (EU) 2017/745 on medical devices]Class I

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Manufacturer: GETEMED Medizin- und Informationstechnik AG

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Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: 0425090320271ND
Device name: HeartX Recorder ECG Patch
Device model: HeartX Recorder ECG Patch
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Version date: Apr 24, 2026

Manufacturer & authorised representative

Manufacturer

Name: GETEMED Medizin- und Informationstechnik AG
SRN: DE-MF-000012384
Country: Germany
Email: schadow@getemed.de
Phone: +49 3328 3942 0

Variants by status

UDI-DI variants

2 UDI-DI variants

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Applied filters

basicUdiUlid01KMNA2KHY3ZBFVD3KQP10NM88

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

HeartX Recorder ECG Patch "F"04250903203121
HeartX Recorder ECG Patch "M"04250903203138