EU → North America Device Access

medical equipment europe GmbH

DE-MF-000014316 · Germany · Hammelburg

medical equipment europe GmbH is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa6

Most frequent device types declared: smart pft CO transfer, smart pft USB, smart pft body, smart pft nebulizer.

Among these devices, 5 are declared active, 4 with a measuring function.

Devices declared under this manufacturer

Catalogue references include 10013, 11001, 13004, 14001, 18003.

European nomenclature codes declared: Z12159003, Z12150101, Z12159005, Z12159007, Z12150199.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED6
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 GTIN6
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. medical equipment europe GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

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