EU → US Device Access

Instrumentation Laboratory SpA

IT-MF-000009277 · Italy · Milan

Instrumentation Laboratory SpA is registered in the European database on medical devices as a manufacturer, with 112 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

other112

Most frequent device types declared: 0018471350, 0001156028, 0018164640, 0001156007, W150039.

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 registerRegistered with FDA
Matched entryINSTRUMENTATION LABORATORY SPA (IT) · FDA 3012348571
Devices in EUDAMED112
Country of registrationItaly

Notified body certificates

CertificateStatusExpiry
V12 034483 0002supplemented2026-11-02

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