EU → US Device Access

UNIVET LOUPES SPA

IT-MF-000027104 · Italy · Rezzato (BS)

UNIVET LOUPES SPA is registered in the European database on medical devices as a manufacturer, with 4 577 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa4 577

Most frequent device types declared: TECHNE, ASH, ITA, TECHNE RX, ONE.

Among these devices, 6 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 registerRegistered with FDA
Matched entryUNIVET LOUPES SPA (IT) · FDA 3018898827
Devices in EUDAMED4 577
Country of registrationItaly

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