EU → North America Device Access

MIRACLE ROBERT BIEGAŃSKI MAŁGORZATA BAUER SPÓŁKA JAWNA

PL-MF-000040195 · Poland · Łódź

MIRACLE ROBERT BIEGAŃSKI MAŁGORZATA BAUER SPÓŁKA JAWNA is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa7

Most frequent device types declared: Exigo.

Among these devices, 7 are declared active.

Devices declared under this manufacturer

Catalogue references include POAD2, POE3, POE4U, POP1, POPE5, POS3.

European nomenclature codes declared: Y210699.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED7
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 GTIN7
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. MIRACLE ROBERT BIEGAŃSKI MAŁGORZATA BAUER SPÓŁKA JAWNA was not found in either the U.S. or the Canadian register.

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