EU → North America Device Access

ANDREW MEDICAL SRL

IT-MF-000029105 · Italy · Carate Brianza

ANDREW MEDICAL SRL is registered in the European database on medical devices as a manufacturer, with 12 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa12

Among these devices, 7 are declared reusable.

Devices declared under this manufacturer

Catalogue references include ANL14SPC, DRI35CNN, MNT23SC, RMNT18SC, SCNN4010SPC, SCR21SPC.

European nomenclature codes declared: L159099, Q010207, L15900899, Q010299, Q010280, P01020180.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED12
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 GTIN12
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. ANDREW MEDICAL SRL was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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