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room4 Softwareentwicklung GmbH

AT-MF-000004591 · Austria · Wien

room4 Softwareentwicklung GmbH is registered in the European database on medical devices as a manufacturer, with 24 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa24

Among these devices, 24 are declared active.

Devices declared under this manufacturer

Showing 12 of 24 declared devices.

Catalogue references include KA BAD - enlivio WebApp, KA BGB- enlivio WebApp, KA GAS - enlivio WebApp, enlivio - ka-bad Patienten-App für Android, enlivio - ka-bgb - enlivio Patienten-App für iOS, enlivio - ka-gas- enlivio Patienten-App für Android.

European nomenclature codes declared: Z12069092.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED24
Country of registrationAustria

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN24
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: Neither register. room4 Softwareentwicklung GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Austria

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