EU → US Device Access

STEELCO S.P.A.

IT-MF-000029689 · Italy · RIESE PIO X

STEELCO S.P.A. is registered in the European database on medical devices as a manufacturer, with 31 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIb19
Class IIa12

Most frequent device types declared: TW 3000/2, DRYERS, ULTRASONIC CLEANING SYSTEM, STEAM STERILIZING UNIT, ETD Mini.

Among these devices, 30 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 entrySTEELCO S.P.A. (IT) · FDA 3005544459
Devices in EUDAMED31
Country of registrationItaly

Notified body certificates

CertificateStatusExpiry
065/MDRamended2027-12-22

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