EU → North America Device Access

ESTABLECIMIENTOS SUMISAN S.A.

ES-MF-000007542 · Spain · SAN SEBASTIAN

ESTABLECIMIENTOS SUMISAN S.A. is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa5

Most frequent device types declared: ABS PREMIUM, PRO70140.

Devices declared under this manufacturer

Catalogue references include ABS ARM, ABS OP EV, ABS PREMIUM, ABXL THERMO EV, PRO70140.

European nomenclature codes declared: A06030499.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED5
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 GTIN5
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. ESTABLECIMIENTOS SUMISAN S.A. was not found in either the U.S. or the Canadian register.

Other manufacturers in Spain

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