EU → North America Device Access

ENforce Medical Technologies Sp. z o.o.

PL-MF-000043797 · Poland · Poznań

ENforce Medical Technologies Sp. z o.o. is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa5

Most frequent device types declared: EAF13,EAF14,EAF15,EAF33,EAF34,EAF35,EAF53,EAF54,EAF55,EAF63,EAF64,EAF6, EDF13,EDF14,EDF15,EDF33,EDF34,EDF35,EDF53,EDF54,EDF55,EDF63,EDF64,EDF6.

Devices declared under this manufacturer

Catalogue references include EAF34, EAF35, EAF54, EAF55, EDF13.

European nomenclature codes declared: Y062403.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED5
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 GTIN5
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. ENforce Medical Technologies Sp. z o.o. was not found in either the U.S. or the Canadian register.

Other manufacturers in Poland

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