EU → US Device Access

PURTEX s.r.o.

CZ-MF-000053672 · Czechia · Zdiby

PURTEX s.r.o. is registered in the European database on medical devices as a manufacturer, with 20 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa20

Most frequent device types declared: Elegans, ANDEMA CLASSIC, VIA.

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 entryPURTEX S.R.O. (CZ) · FDA 3038188186
Devices in EUDAMED20
Country of registrationCzechia

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