EU → North America 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.

Devices declared under this manufacturer

Showing 12 of 42 declared devices.

Catalogue references include FBRX06L, LYO-010X010H, LYO-025X030H, LYO-060X080H, LYO-060X120H, LYO-075X075H.

European nomenclature codes declared: P900402.

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; we do not assert it is the same company — why.

Device-level evidence

Devices with a numeric GTIN42
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

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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