EU → North America Device Access

ACTO GmbH

DE-MF-000019128 · Germany · Braunschweig

ACTO GmbH is registered in the European database on medical devices as a manufacturer, with 221 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa65
Class I110
Class IIb46

Most frequent device types declared: Aclind w Gel 5*10 ml, Aclind w Solution 50 ml, Actoanid Spray 1 L, Actoanid Wipes 100 wipes, Actolind w Gel 05M25.

Devices declared under this manufacturer

Showing 12 of 221 declared devices.

Catalogue references include 01.4702.5, 02.3404.2, 05.1210.100, 05.1230.1, 06.3798.250, 06.3848.50.

European nomenclature codes declared: M040412, D0799, D0901, D0299, M9002, D050103.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED221
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 GTIN221
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. ACTO GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

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