EU → US Device Access

NSK Dental Italy S.r.l.

IT-MF-000022193 · Italy · Thiene

NSK Dental Italy S.r.l. is registered in the European database on medical devices as a manufacturer, with 24 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb24

Most frequent device types declared: Autoclave iClave 18/24 - DXPclave 18/24, 91800B0300, 90600S0101, 91800B0300P, 91808B0201.

Among these devices, 22 are declared active, 1 with a measuring function.

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 EUDAMED24
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
G10 111928 0001withdrawn2028-07-25
296/MDRissued2028-07-25

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