EU → US Device Access

Parabel s.r.o.

CZ-MF-000002892 · Czechia · Lukov

Parabel s.r.o. is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa6

Most frequent device types declared: LokoStation 55, LokoBasic.

Among these devices, 4 are declared active.

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 entryPARABEL S.R.O. (CZ) · FDA 3007710870
Devices in EUDAMED6
Country of registrationCzechia

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