EU → North America Device Access

ŠTĚPAŘ s.r.o.

CZ-MF-000023035 · Czechia · Polička

ŠTĚPAŘ s.r.o. is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa6

Most frequent device types declared: N2.5x5, Pryžové obinadlo škrticí 25 x 750 mm, RLX, Rouška resuscitační s plastovým náustkem.

Devices declared under this manufacturer

Catalogue references include N2.5x5, RLX, RR, SAT, SKR25, SKR60.

European nomenclature codes declared: M0304010101, R030199, M0599, M030501, T010299.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED6
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 GTIN6
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. ŠTĚPAŘ s.r.o. was not found in either the U.S. or the Canadian register.

Other manufacturers in Czechia

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