EU → North America Device Access

"ECOMED" Marcin Fortuna

PL-MF-000047404 · Poland · Brochów

"ECOMED" Marcin Fortuna is registered in the European database on medical devices as a manufacturer, with 11 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa11

Most frequent device types declared: Stetoskop.

Devices declared under this manufacturer

Catalogue references include AC44L, IC44D, IC44S, IN44, KC50, KN50.

European nomenclature codes declared: C9005.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED11
Country of registrationPoland

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

Device-level evidence

Devices with a numeric GTIN11
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. "ECOMED" Marcin Fortuna was not found in either the U.S. or the Canadian register.

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