EU → North America Device Access

Almax Imaging srl

IT-MF-000028923 · Italy · Bergamo

Almax Imaging srl 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 IIb16

Most frequent device types declared: ALMA C FP +21.

Among these devices, 16 are declared active.

Catalogue references include 11.01.800.001, 11.01.800.006, 11.01.800.009, 11.01.800.011, 11.01.800.012, 11.01.800.014.

European nomenclature codes declared: Z11039017.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED16
Country of registrationItaly

⚠️ 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. Almax Imaging srl was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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