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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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Organization name
UDI-DI code
Reference / catalog number

M2 — Class I MDR by Medirecord CZ s.r.o.

MD Atlas
Medirecord CZ s.r.o.

EUDAMED last updated this device on Sep 23, 2025

M2

859423026MDRSYSTEMM2XR

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Medirecord CZ s.r.o.
UDI-DI code: 08594230260003
Reference / catalog number: M2

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Manufacturer information

Organization name: Medirecord CZ s.r.o.
SRN: CZ-MF-000049661
Manufacturer status: Active

Market distribution

Primary placement in Czechia; available across 2 countries total.

Country	On market since	Until
CzechiaPrimary placement	Oct 1, 2025	Still on market
Slovakia	Oct 1, 2025	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08594230260003
Basic UDI-DI: 859423026MDRSYSTEMM2XR
Reference / catalog number: M2
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: A medical device intended for recording, archiving, streaming, signal routing, and post-processing of medical procedures, enabling retrospective evaluation of procedures and supporting clinical decision-making. The software is not intended for direct diagnosis or for therapeutic interventions.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z11069092VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - 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.