EU → North America Device Access

ATO FORM GmbH

DE-MF-000008880 · Germany · Sailauf

ATO FORM GmbH is registered in the European database on medical devices as a manufacturer, with 2 997 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa2 997

Among these devices, 82 are declared active.

Devices declared under this manufacturer

Showing 12 of 2 997 declared devices.

Catalogue references include 5183-2-52, 5183-66, 5185-4-55, 5190VI-1-52, 5383-1-59, 5583-2-60.

European nomenclature codes declared: Y090699, V08050399, Y180980, Y0999, T0499, Y0580.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED2 997
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 GTIN2 997
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. ATO FORM GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

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