EU → North America Device Access

Sapio Life S.r.l.

IT-MF-000028368 · Italy · Monza

Sapio Life S.r.l. 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 IIa2
Class IIb10

Most frequent device types declared: Impianto del vuoto, Impianto di distribuzione gas medicali compressi, Impianto di evacuazione dei gas anestetici.

Among these devices, 12 are declared active.

Catalogue references include Not Applicable.

European nomenclature codes declared: Z120309.

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. Sapio Life S.r.l. was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
62272issued2031-04-12

Other manufacturers in Italy

All Italy manufacturers →