EU → North America Device Access

NEGRI SRL

IT-MF-000035473 · Italy · STANGHELLA

NEGRI SRL is registered in the European database on medical devices as a manufacturer, with 15 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa2
Class IIb13

Most frequent device types declared: LEMON ACID, NENG1100NG1, NENG1360NG1, NENG6500NG6, NGLAS5LT.

Among these devices, 10 are declared sterile, 9 active.

Devices declared under this manufacturer

Showing 12 of 15 declared devices.

Catalogue references include 2387745, NENG1100NG1, NENG6500NG6, NGLAS5LT, NGLDX1KG, NGLSPY1000.

European nomenclature codes declared: Q02030204, D06010199, D050103, D020199, D99, D0901.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED15
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 GTIN9
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. NEGRI SRL was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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