EU → North America Device Access

INNOVACIONES DISRAS SL

ES-MF-000003854 · Spain · DON BENITO

INNOVACIONES DISRAS SL is registered in the European database on medical devices as a manufacturer, with 18 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Class IIa18

Most frequent device types declared: OTOSTICK (8 und.).

Devices declared under this manufacturer

Showing 12 of 18 declared devices.

Catalogue references include 8437010702006, 8437010702235, 8437010702426, 8437010702457, 8437010702655, 8437010702679.

European nomenclature codes declared: V9099.

United States market access

FDA establishment registerSimilar name found — unverified
Matched entryINNOVACIONES DISRAS S L (ES) · FDA 3011363737
Devices in EUDAMED18
Country of registrationSpain

⚠️ A similar name exists; we do not assert it is the same company — why.

Device-level evidence

Devices with a numeric GTIN18
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.

Other manufacturers in Spain

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