EU → US Device Access

Project Engineering srl

IT-MF-000009571 · Italy · Impruneta

Project Engineering srl is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb6

Most frequent device types declared: On Demand / Endless , On Demand / Endless, Endless, On Demand.

Among these devices, 6 are declared active, 6 with a measuring function.

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 EUDAMED6
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
MDR 00154-Aissued2031-06-04

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