EU → North America Device Access

Easytech S.r.l.

IT-MF-000017907 · Italy · Borgo San Lorenzo

Easytech S.r.l. is registered in the European database on medical devices as a manufacturer, with 19 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa8
Class IIb11

Most frequent device types declared: Crio-terapia, Ipertermia, Isocinetica, Isocinetica_ISO, Resistenza elastica.

Among these devices, 16 are declared active, 2 with a measuring function.

Devices declared under this manufacturer

Showing 12 of 19 declared devices.

Catalogue references include 80000305, 80000550, 80000580, 80000685, 80000690, 80000950.

European nomenclature codes declared: Z12069099, Z120603, Z120601.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED19
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 GTIN19
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. Easytech S.r.l. was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
ITH 1343914 1amended2027-07-19

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