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Organization name
UDI-DI code
Reference / catalog number

RAIDAS — Class IIa MDR by AIgnostikum GmbH

MD Atlas
AIgnostikum GmbH

EUDAMED last updated this device on Apr 7, 2026

RAIDAS

42700043623RAIDASNU

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: AIgnostikum GmbH
UDI-DI code: 04270004362305
Reference / catalog number: RAIDAS

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Manufacturer information

Organization name: AIgnostikum GmbH
SRN: AT-MF-000042449
Manufacturer status: Active

Market distribution

Primary placement in Austria; available across 2 countries total.

Country	On market since	Until
AustriaPrimary placement	Oct 7, 2025	Oct 6, 2030
Germany	Oct 7, 2025	Oct 6, 2030

Device identification

Trade name: not provided
UDI-DI code: 04270004362305
Basic UDI-DI: 42700043623RAIDASNU
Reference / catalog number: RAIDAS
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: RAIDAS (short for "Radiology AI Diagnostic Assistant System") is a software product intended to assist radiologists in the evaluation of MRI images. The software is intended to be used as a diagnostic aid, providing additional information to support the radiologist's clinical decision-making process.
Additional information URL: https://www.aignostikum.at/
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

Certificate health across this manufacturer's portfolio.

MDR-0030Issued
Quality management systemNotified body: 1304Expiry: Oct 6, 2030