EU → North America Device Access

em-tec GmbH

DE-MF-000008066 · Germany · Finning

em-tec GmbH is registered in the European database on medical devices as a manufacturer, with 17 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa17

Most frequent device types declared: aQuila.

Among these devices, 17 are declared active, 17 with a measuring function.

Devices declared under this manufacturer

Showing 12 of 17 declared devices.

Catalogue references include 13475, 13478, 13481, 13858, 13874, 14002.

European nomenclature codes declared: Z12040111.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED17
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 GTIN17
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryEM-TEC GMBH

North American profile: Canada only. em-tec GmbH holds a Canadian licence but was not found in the U.S. register.

Other manufacturers in Germany

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