EU → US Device Access

Meditec Source GmbH & Co. KG

DE-MF-000006490 · Germany · Tuttlingen

Meditec Source GmbH & Co. KG is registered in the European database on medical devices as a manufacturer, with 177 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa177

Most frequent device types declared: Screwdriver, Depth Gauge, Bohrbuchsen\t\t, Führungsdrähte\t\t, Fräser.

Among these devices, 177 are declared reusable, 24 with a measuring function.

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 entryMEDITEC SOURCE GmbH & Co. KG (DE) · FDA 3009468807
Devices in EUDAMED177
Country of registrationGermany

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