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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

2.2 — Class IIb MDR by Aireen a.s.

MD Atlas
Aireen a.s.

EUDAMED last updated this device on Aug 21, 2025

2.2

859421121AIREEN2HF

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Aireen a.s.
UDI-DI code: 08594211210089
Reference / catalog number: 2.2

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Manufacturer information

Organization name: Aireen a.s.
SRN: CZ-MF-000027736
Manufacturer status: Active

Market distribution

Primary placement in Czechia; available across 3 countries total.

Country	On market since	Until
CzechiaPrimary placement		Still on market
Hungary		Still on market
Slovakia		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08594211210089
Basic UDI-DI: 859421121AIREEN2HF
Reference / catalog number: 2.2
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

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.

2023-MDR/QS-006/CSupplemented
Quality management systemNotified body: 2265Expiry: May 19, 2028