EU → North America Device Access

S.M.D. S.R.L.

IT-MF-000029648 · Italy · Cadriano - Granarolo dell'Emilia (BO)

S.M.D. S.R.L. is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa7

Most frequent device types declared: ARCADIA, ATLAS-A, DENEB-A, LUNAR-A, POILAR A.

Among these devices, 7 are declared active.

Devices declared under this manufacturer

Catalogue references include 3910310, 3911300, 3912300, 3913600, 3915620, 3945200.

European nomenclature codes declared: Z12139004, Z12010780, V08020199.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED7
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 GTIN7
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. S.M.D. S.R.L. was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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