EU → North America Device Access

Merck KGaA

DE-MF-000018777 · Germany · Darmstadt

Merck KGaA is registered in the European database on medical devices as a manufacturer, with 167 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Devices declared under this manufacturer

Showing 12 of 167 declared devices.

Catalogue references include 1005671000, 1005672500, 1085620050, 1092042500, 1092531000, 1118850001.

European nomenclature codes declared: W01030708, W0104010804, W0103010302, W01030706, W010399, W01030704.

United States market access

FDA establishment registerRegistered with FDA
Matched entryMERCK KGAA (DE) · FDA 9610140
Devices in EUDAMED167
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN167
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: United States only. Merck KGaA is registered in the United States but was not found in the Canadian register.

Other manufacturers in Germany

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