EU → North America Device Access

Puma Srl

IT-MF-000047643 · Italy · Settimo Milanese

Puma Srl is registered in the European database on medical devices as a manufacturer, with 160 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa160

Most frequent device types declared: PRO METAL SW, Pro 30, Pro28F, Pro35F, Pro45S.

Devices declared under this manufacturer

Showing 12 of 160 declared devices.

Catalogue references include PRO 28F, PRO 30, PRO 35 F, PRO 45 S, PRO METAL SW, pro 28.

European nomenclature codes declared: Z12149002.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED160
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 GTIN160
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. Puma Srl was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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