EU → North America Device Access

Simonsen & Weel A/S

DK-MF-000035987 · Denmark · Ishøj

Simonsen & Weel A/S is registered in the European database on medical devices as a manufacturer, with 139 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa139

Most frequent device types declared: Pad semi circular shaped 500, bariatric.

Among these devices, 1 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 139 declared devices.

Catalogue references include 229271, 229628, 229903, 239932, 249082, 249089.

European nomenclature codes declared: V080399.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED139
Country of registrationDenmark

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

Device-level evidence

Devices with a numeric GTIN139
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. Simonsen & Weel A/S was not found in either the U.S. or the Canadian register.

Other manufacturers in Denmark

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