EU → North America Device Access

4TEK SRL

IT-MF-000014881 · Italy · PADERNO DUGNANO

4TEK SRL is registered in the European database on medical devices as a manufacturer, with 164 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa164

Most frequent device types declared: A006, AIR RING SUCTION, ECO, ECO LINE – More Than One Head, LIQUID RING SUCTION.

Among these devices, 164 are declared active.

Devices declared under this manufacturer

Showing 12 of 164 declared devices.

Catalogue references include COECO4NME, COECOS28E, COMIR070E, COMIR07MN, COMIR130E, COMIR131E.

European nomenclature codes declared: Z12110199.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED164
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 GTIN164
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. 4TEK SRL was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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