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EMTEL Śliwa spółka komandytowa

PL-MF-000006848 · Poland · Zabrze

EMTEL Śliwa spółka komandytowa is registered in the European database on medical devices as a manufacturer, with 74 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb19
Class IIa55

Most frequent device types declared: DefiMax AED, DefiMax Plus, DefiMax mobile, E4001, E4004, E4005, E4006, E4007, E4008, E4009, E4010, E4011, E4013, , ECG Cables and Leadwires.

Among these devices, 19 are declared active, 19 with a measuring function.

Devices declared under this manufacturer

Showing 12 of 74 declared devices.

Catalogue references include DEFIMAXPLUS, E1131, E1510, E3012, E4008, E4009.

European nomenclature codes declared: Z1203020285, Z1203020201, Z1203020285,Z12030585, Z1203020599, Z12030502, Z1203020299.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED74
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 GTIN74
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. EMTEL Śliwa spółka komandytowa was not found in either the U.S. or the Canadian register.

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