EU → North America Device Access

Talleres Mestraitua, S.L.

ES-MF-000004344 · Spain · SONDIKA

Talleres Mestraitua, S.L. is registered in the European database on medical devices as a manufacturer, with 19 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa19

Most frequent device types declared: Alginate mixer, Crown extractor, Light curing base plates, Láminas de termoconformado / Vacuum forming sheets, Mango de espejo / Mirror handle.

Among these devices, 1 are declared active.

Devices declared under this manufacturer

Showing 12 of 19 declared devices.

Catalogue references include 080802-05, 080802-10, 080803-05, 080803-10, 080804-05, 080804-10.

European nomenclature codes declared: Q010699, Q01020199, L160201, Q010199, L15900699.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED19
Country of registrationSpain

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

Device-level evidence

Devices with a numeric GTIN19
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: Neither register. Talleres Mestraitua, S.L. was not found in either the U.S. or the Canadian register.

Other manufacturers in Spain

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