EU → North America Device Access

Home Diagnostics S.L

ES-MF-000026858 · Spain · Madrid

Home Diagnostics S.L is registered in the European database on medical devices as a manufacturer, with 13 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa1

Most frequent device types declared: AILIN.

Among these devices, 1 are declared active.

Devices declared under this manufacturer

Showing 12 of 13 declared devices.

Catalogue references include 01, 03, 04, 18, REFERENCIA 11, REFERENCIA 12.

European nomenclature codes declared: A99, V92, W02060292.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED13
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 GTIN13
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. Home Diagnostics S.L was not found in either the U.S. or the Canadian register.

Other manufacturers in Spain

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