EU → North America Device Access

AoN Implants

IT-MF-000011061 · Italy · Grisignano di Zocco

AoN Implants is registered in the European database on medical devices as a manufacturer, with 1 104 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb618
Class IIa486

Among these devices, 638 are declared sterile, 618 implantable, 316 reusable.

Devices declared under this manufacturer

Showing 12 of 1 104 declared devices.

Catalogue references include A2G5N115CMCAB, AAN35000TT00B, ACG40000CMIMC, ACG4007000ST0, ACG42160FRFF0, AIF42150N2000.

European nomenclature codes declared: P01020101, L159099, Q0199, Q010207, Q019005.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED1 104
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 GTIN1 104
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. AoN Implants was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
0425-MDR-030062-01issued2029-01-16

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