EU → North America Device Access

I.A.C.E.R. Srl

IT-MF-000009126 · Italy · Scorzè

I.A.C.E.R. Srl is registered in the European database on medical devices as a manufacturer, with 17 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa17

Among these devices, 17 are declared active.

Devices declared under this manufacturer

Showing 12 of 17 declared devices.

Catalogue references include 10108, 10513, 10514, 10515, 10519, 40514.

European nomenclature codes declared: Z120607, Z120606.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED17
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 GTIN17
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.

North American profile: Neither register. I.A.C.E.R. Srl was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
ITH 1344294 1amended2028-01-15

Other manufacturers in Italy

All Italy manufacturers →