EU → North America Device Access

Merckle GmbH

DE-MF-000018230 · Germany · Ulm

Merckle 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 IIa8
Class IIb2
Class I1

Among these devices, 2 are declared sterile.

Devices declared under this manufacturer

Catalogue references include 251267, 266677, 269931, 269955, 305425, 307356.

European nomenclature codes declared: V9099.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED11
Country of registrationGermany

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

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. Merckle GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

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