EU → North America 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: 90600S0101, 90600S0201, 90601S0201, 91800B0100P, 91800B0300.

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

Devices declared under this manufacturer

Showing 12 of 24 declared devices.

Catalogue references include 90600S0101, 91800B0300, 91800B0300P, 91808B0201, 91811B0100, 91812B0100P.

European nomenclature codes declared: Z12011305.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED24
Country of registrationItaly

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

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. NSK Dental Italy S.r.l. was not found in either the U.S. or the Canadian register.

Notified body certificates

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

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