EU → North America Device Access

IDROFIL S.R.L

IT-MF-000034167 · Italy · Marcianise

IDROFIL S.R.L is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa8

Most frequent device types declared: Confezione da: g 1000; g 250; g 200; g 100; g 80; g 50, Traverse Monouso non rimboccabili.

Devices declared under this manufacturer

Catalogue references include 05.004, 05.005, 17.050, 17.080, 17.100, 17.101.

European nomenclature codes declared: M010101, M010199.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED8
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 GTIN8
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. IDROFIL S.R.L was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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