EU → US 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.

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 registerNot found in the FDA register
Devices in EUDAMED1 104
Country of registrationItaly
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

Notified body certificates

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

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