EU → North America Device Access

STEM SRL

IT-MF-000028768 · Italy · MEDESANO

STEM SRL is registered in the European database on medical devices as a manufacturer, with 10 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa10

Among these devices, 6 are declared active.

Devices declared under this manufacturer

Catalogue references include SALLY-SPARK, SPARK-FS, SPYKE-FS, SPYKE-UC, STR001, STR002.

European nomenclature codes declared: V08050101, V0880, V08050104.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED10
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 GTIN10
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. STEM SRL was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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