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Elektronika i Elektromedycyna M.Lewandowski Sp.J.

PL-MF-000032400 · Poland · Otwock

Elektronika i Elektromedycyna M.Lewandowski Sp.J. is registered in the European database on medical devices as a manufacturer, with 76 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa76

Most frequent device types declared: Electrotherapy equipment - Electrode, Electrotherapy equipment - pad, Electrotherapy equipment – band, Electrotherapy equipment – cable, Magnetotherapy equipment.

Among these devices, 14 are declared active.

Devices declared under this manufacturer

Showing 12 of 76 declared devices.

Catalogue references include Couch L-6, E-8M, K-2LW, Magnetronic MF-24, O-R1, P-36.

European nomenclature codes declared: N010201, N01028001, N01028099, N01028003, V0899, Z120601,Z120610,Z120615.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED76
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 GTIN76
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. Elektronika i Elektromedycyna M.Lewandowski Sp.J. was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
TNP/MDR/0030/2034/2025issued2028-01-16

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