EU → US Device Access

Aesku.Diagnostics GmbH & Co. KG

DE-MF-000026925 · Germany · Wendelsheim

Aesku.Diagnostics GmbH & Co. KG is registered in the European database on medical devices as a manufacturer, with 162 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

other162

Most frequent device types declared: 20110008, 20110009, 20110007.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerRegistered with FDA
Matched entryAESKU.DIAGNOSTICS GmbH&Co.KG (DE) · FDA 3003825930
Devices in EUDAMED162
Country of registrationGermany

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