EU → North America Device Access

I.A.E. INDUSTRIA APPLICAZIONI ELETTRONICHE S.P.A.

IT-MF-000021626 · Italy · Bergamo (BG)

I.A.E. INDUSTRIA APPLICAZIONI ELETTRONICHE S.P.A. is registered in the European database on medical devices as a manufacturer, with 95 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb95

Among these devices, 95 are declared active.

Devices declared under this manufacturer

Showing 12 of 95 declared devices.

Catalogue references include 0.3/0.6, C340 V, RTM 30 HS 0.3/0.6, RTM 70 HS 0.3/0.6, RTM 77 H 0.6/1.25, X40 S 1.0/2.0.

European nomenclature codes declared: Z11039099.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED95
Country of registrationItaly

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN95
Found in the U.S. device database88
Share92.6 %
⚠ The two levels disagree here. This company’s name was not found in the FDA establishment register, yet some of its devices are in the U.S. device database. The likeliest reading is that the name match failed.

Canadian market access

Health Canada licence listingNot found in the Canadian register

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

North American profile: Neither register. I.A.E. INDUSTRIA APPLICAZIONI ELETTRONICHE S.P.A. was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
029/MDRamended2027-04-27

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