EU → US Device Access

AUDIO TECHNOLOGIES SRL

IT-MF-000010733 · Italy · Gossolengo (PC)

AUDIO TECHNOLOGIES SRL is registered in the European database on medical devices as a manufacturer, with 42 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Class I42

Among these devices, 42 are declared sterile, 42 implantable.

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 registerSimilar name found — unverified
Matched entryAUDIO TECHNOLOGIES S.R.L. (IT) · FDA 9616949
Devices in EUDAMED42
Country of registrationItaly
⚠️ A similar name exists in the FDA register. We do not assert that it is the same company — the two registers share no common identifier, and a name alone is not proof. This entry needs a human check.

Notified body certificates

CertificateStatusExpiry
EPT 0477.MDR.24/5442.1reissued2027-08-25
EPT 0477.MDR.24/5441.1reissued2027-08-25
EPT 0477.MDR.22/4918issued2027-08-25
EPT 0477.MDR.22/4917issued2027-08-25

Other manufacturers in Italy

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