EU → US Device Access

UNION DENTAL S.A.

ES-MF-000003189 · Spain · TIELMES

UNION DENTAL S.A. is registered in the European database on medical devices as a manufacturer, with 6 195 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa6 195

Most frequent device types declared: Artificial Teeth.

Among these devices, 2 are declared implantable.

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 registerRegistered with FDA
Matched entryUNION DENTAL S.A. (ES) · FDA 3005350578
Devices in EUDAMED6 195
Country of registrationSpain

Notified body certificates

CertificateStatusExpiry
2025 CR 0043supplemented2030-02-09

Other manufacturers in Spain

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