EU → North America Device Access

MDT sp. z o.o.

PL-MF-000009248 · Poland · Kraków

MDT sp. z o.o. is registered in the European database on medical devices as a manufacturer, with 59 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa59

Among these devices, 42 are declared active.

Devices declared under this manufacturer

Showing 12 of 59 declared devices.

Catalogue references include CRP-130, CRP-90, MD-1, PL-232, SMART PLUS, TRU-2500.

European nomenclature codes declared: Q0299, Q0209, T0306.

United States market access

FDA establishment registerRegistered with FDA
Matched entryMDT SP. Z O.O. (PL) · FDA 3010755771
Devices in EUDAMED59
Country of registrationPoland

Device-level evidence

Devices with a numeric GTIN59
Found in the U.S. device database42
Share71.2 %

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: United States only. MDT sp. z o.o. is registered in the United States but was not found in the Canadian register.

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