EU → North America Device Access

Ing. Petr Švec - PENTA s.r.o.

CZ-MF-000035988 · Czechia · Praha

Ing. Petr Švec - PENTA s.r.o. is registered in the European database on medical devices as a manufacturer, with 37 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Devices declared under this manufacturer

Showing 12 of 37 declared devices.

Catalogue references include 10660, 12830, 14090, 14680-11000, 20110-11000, 25100.

European nomenclature codes declared: W01030708, W0104080299, W01030199, W0104080203, W0101060299, W01030799.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED37
Country of registrationCzechia

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN37
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: Neither register. Ing. Petr Švec - PENTA s.r.o. was not found in either the U.S. or the Canadian register.

Other manufacturers in Czechia

All Czechia manufacturers →