EU → US 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 IIb10
Class IIa2

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

Among these devices, 12 are declared active.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED12
Country of registrationItaly
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

Notified body certificates

CertificateStatusExpiry
62272issued2031-04-12

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