EU → US Device Access

ASA S.r.l.

IT-MF-000007966 · Italy · ARCUGNANO (VI)

ASA S.r.l. is registered in the European database on medical devices as a manufacturer, with 59 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIb36
Class IIa23

Most frequent device types declared: HANDPIECE, MPHI, HIRO TT, MAGNETO BED, MAGNETO QS.

Among these devices, 53 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 entryASA S.R.L. (IT) · FDA 3004724437
Devices in EUDAMED59
Country of registrationItaly

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