EU → North America Device Access

WE Medical B.V.

NL-MF-000002700 · Netherlands · Maastricht

WE Medical B.V. is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa6

Most frequent device types declared: Bottle nose, Spray, Super absorbent gelling agent, WC200, WEM150-30.

Devices declared under this manufacturer

Catalogue references include WC200, WEM150-30, WEM151-30, WEM152-50, WEM154-50, WEM155-60.

European nomenclature codes declared: A108005, A1099, A108004.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED6
Country of registrationNetherlands

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

Device-level evidence

Devices with a numeric GTIN6
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. WE Medical B.V. was not found in either the U.S. or the Canadian register.

Other manufacturers in Netherlands

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