EU → North America Device Access

REVITA Ewa Krutul

PL-MF-000015607 · Poland · Mścice

REVITA Ewa Krutul is registered in the European database on medical devices as a manufacturer, with 17 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa17

Most frequent device types declared: 350PCV, ALA, ALFA, BARIA, GAMMA.

Among these devices, 15 are declared active.

Catalogue references include 05904209543588, 05904209543595, 05904933596553, 05904933596584, 05904933596614, 05904933596621.

European nomenclature codes declared: V080701, V08030101, V08030102.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED17
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 GTIN17
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. REVITA Ewa Krutul was not found in either the U.S. or the Canadian register.

Other manufacturers in Poland

All Poland manufacturers →