EU → North America Device Access

GMI Dental Implantology, S.L.

ES-MF-000024246 · Spain · Lleida

GMI Dental Implantology, S.L. is registered in the European database on medical devices as a manufacturer, with 404 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa404

Most frequent device types declared: 843656274KDI00E2, 843656274KDS00FL, 843656274KPA00FE, 843656274KYF00J6, 843656274KYL00K4.

Among these devices, 261 are declared reusable.

Catalogue references include KDI0F4004, KDI0F4006, KYF0C4359, KYF0C6501, KYF0C6537, KYL0F0096.

European nomenclature codes declared: Q010399, Q0199, Q010207.

United States market access

FDA establishment registerRegistered with FDA
Matched entryGMI DENTAL IMPLANTOLOGY, S.L. (ES) · FDA 3009847764
Devices in EUDAMED404
Country of registrationSpain

Device-level evidence

Devices with a numeric GTIN404
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: United States only. GMI Dental Implantology, S.L. is registered in the United States but was not found in the Canadian register.

Other manufacturers in Spain

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