EU → North America Device Access

FIORENTINO A.M. S.r.l.

IT-MF-000035747 · Italy · ROMA

FIORENTINO A.M. 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: Strumentazione per interventi terapeutici.

Among these devices, 7 are declared active.

Devices declared under this manufacturer

Catalogue references include AMF 201/HS, AMF 201/PY, AMF 201/TR, AMF 26/XC, AMF 27/TM, AMF 29/6X.

European nomenclature codes declared: Z12129099, Z129099, Z12120199, Z12129001.

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. FIORENTINO A.M. S.r.l. was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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