EU → US Device Access

Delcon Srl

IT-MF-000014234 · Italy · Grassobbio (BG)

Delcon Srl is registered in the European database on medical devices as a manufacturer, with 66 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa47
other19

Most frequent device types declared: Fixing/Cleaning solution, Hematology Fixative/Cleaning solution .

Among these devices, 47 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 entryDELCON SRL (IT) · FDA 3014345398
Devices in EUDAMED66
Country of registrationItaly

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