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Organization name
UDI-DI code
Reference / catalog number

2024.39.x — Class IIa MDR by apoplex medical…

MD Atlas
apoplex medical technologies GmbH

EUDAMED last updated this device on Aug 12, 2025

2024.39.x

426070159A0002B0000G4

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: apoplex medical technologies GmbH
UDI-DI code: 04260701590071
Reference / catalog number: 2024.39.x

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Manufacturer information

Organization name: apoplex medical technologies GmbH
SRN: DE-MF-000025052
Manufacturer status: Active

Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

CW010
Patient must be over 18 years of age
CW030
Do not use for patients with a pacemaker device

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Jan 1, 2026	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04260701590071
Basic UDI-DI: 426070159A0002B0000G4
Reference / catalog number: 2024.39.x
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: SRAi is a medical device software that aids medical professionals in the analysis of ECG sig-nals. The product is designed to: 1. Provide information to support the user in the decision for further diagnostics, 2. Analyze ECG data for patients in non-serious situations or conditions where treatment is normally not expected to be time-critical.
Additional information URL: https://www.apoplexmedical.com/de/download/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12050392ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

This device is not currently linked to any other device.

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.