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EM-MED Spółka z ograniczoną odpowiedzialnością spółka komandytowa

PL-MF-000004822 · Poland · Kraków

EM-MED Spółka z ograniczoną odpowiedzialnością spółka komandytowa is registered in the European database on medical devices as a manufacturer, with 16 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa16

Most frequent device types declared: 1D, 2D, 3DS, 3DW, TCB-21C, TCB-21V, TCB-31C, TCB-31V, TCB-61C, TCB-61V, TCM-21V, TCM-31V.

Catalogue references include 5907222570524, EMT2D, TCB-21C, TCB-21V, TCB-31V, TCM-21V.

European nomenclature codes declared: V9099.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED16
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 GTIN16
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. EM-MED Spółka z ograniczoną odpowiedzialnością spółka komandytowa was not found in either the U.S. or the Canadian register.

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