EU → North America Device Access

DEZIMAL GmbH

AT-MF-000055329 · Austria · Wien

DEZIMAL GmbH is registered in the European database on medical devices as a manufacturer, with 11 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa11

Most frequent device types declared: Cylindrical lens, IOL shuttle, RALV APP, RALV Device, ZERO shuttle.

Among these devices, 2 are declared active.

Devices declared under this manufacturer

Catalogue references include 12253-1100, 12253-1208, 12253-1209, 12253-1210, 12253-1211, 12253-1213.

European nomenclature codes declared: Q0299.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED11
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 GTIN11
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. DEZIMAL GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Austria

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