EU → North America Device Access

IBK Systeme GmbH

DE-MF-000006941 · Germany · Aalen

IBK Systeme GmbH is registered in the European database on medical devices as a manufacturer, with 9 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa9

Among these devices, 9 are declared active.

Devices declared under this manufacturer

Catalogue references include MultiVisus 23,8\, MultiVisus 24\, VISUCAT 23,8 MH, VISUCAT 23,8\, VISUCAT 24\, VISUCAT 32\.

European nomenclature codes declared: Q0299.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED9
Country of registrationGermany

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

Device-level evidence

Devices with a numeric GTIN9
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. IBK Systeme GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

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