EU → North America Device Access

ERABAKI2010

ES-MF-000014588 · Spain · Cizur Menor

ERABAKI2010 is registered in the European database on medical devices as a manufacturer, with 11 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa11

Devices declared under this manufacturer

Catalogue references include B2314, DULET, KRK5L, KRK6090, MA7237, PAD75150.

European nomenclature codes declared: T030199.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED11
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 GTIN11
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. ERABAKI2010 was not found in either the U.S. or the Canadian register.

Other manufacturers in Spain

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