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Organization name
UDI-DI code
Reference / catalog number

KITMed 2.2 — Class IIa MDR by AIT Austrian Institute…

MD Atlas
AIT Austrian Institute of Technology GmbH

EUDAMED last updated this device on Mar 10, 2025

KITMed 2.2

912010983KITMed2NV

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: AIT Austrian Institute of Technology GmbH
UDI-DI code: 09120109830283
Reference / catalog number: KITMed 2.2

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Manufacturer information

Organization name: AIT Austrian Institute of Technology GmbH
SRN: AT-MF-000002398
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW011
Patients with indication for intensive medicinal treatment are excluded from the use of KITMed. KITMed is not intended for use in emergency medical care. The patient must be informed that in the event of an emergency the family doctor or the local rescue or emergency medical service must be contacted directly. KITMed is not intended for the use in intensive care or for monitoring patients in intensive care. Patients with an indication for intensive care are excluded from the use of KITMed.

Market distribution

Primary placement in Austria; available across 2 countries total.

Country	On market since	Until
AustriaPrimary placement		Still on market
Germany		Still on market

Device identification

Trade name: not provided
UDI-DI code: 09120109830283
Basic UDI-DI: 912010983KITMed2NV
Reference / catalog number: KITMed 2.2
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: —
Additional information URL: https://kit.ait.ac.at/wp-content/uploads/2025/03/KITMed-2.2.0-Instruction-for-Use_V4.3_2025-01-10.pdf
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

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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.