EU → North America Device Access

Moltoplast GmbH

AT-MF-000004503 · Austria · Innsbruck

Moltoplast GmbH is registered in the European database on medical devices as a manufacturer, with 559 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa559

Among these devices, 5 are declared active.

Devices declared under this manufacturer

Showing 12 of 559 declared devices.

Catalogue references include 6301104131, 6501001230, MAPFM4OHNE, MAPFMAVERLÄNGERUNG, XROLCLIMA60BW, XROLMOBW STK.

European nomenclature codes declared: V08030102,V080302, V080702, V0880, V08030102, M04040601, V0899.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED559
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 GTIN559
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. Moltoplast GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Austria

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