EU → North America Device Access

PLURITEX SRL

IT-MF-000024111 · Italy · FIORENZUOLA D'ARDA (PC)

PLURITEX SRL is registered in the European database on medical devices as a manufacturer, with 254 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa254

Among these devices, 2 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 254 declared devices.

Catalogue references include 1G0043, 1G01-A TG.4XL, 95H66C, 97H06, AA023, AA052.

European nomenclature codes declared: T020199, T020401, T020402, T020499, T020103.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED254
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 GTIN254
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. PLURITEX SRL was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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