EU → North America Device Access

Fleming Medical

IE-MF-000044303 · Ireland · Limerick

Fleming Medical is registered in the European database on medical devices as a manufacturer, with 214 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa203
Class IIb11

Devices declared under this manufacturer

Showing 12 of 214 declared devices.

Catalogue references include GMD0030, MD1801, MD536LG, MD758, PX230LG, PX301.

European nomenclature codes declared: M030499, M030402020101, M03030202, H900299, V9012, M9001.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED214
Country of registrationIreland

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN214
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. Fleming Medical was not found in either the U.S. or the Canadian register.

Other manufacturers in Ireland

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