EU → North America Device Access

Concept Medical B.V.

NL-MF-000011506 · Netherlands · Hoevelaken

Concept Medical B.V. is registered in the European database on medical devices as a manufacturer, with 1 658 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class I1 170
Class IIa487

Among these devices, 1 658 are declared sterile, 256 implantable.

Devices declared under this manufacturer

Showing 12 of 1 658 declared devices.

Catalogue references include CMDW18007, CMDW18027, CMDW18032, CMDW35208, CME27530, CPT18350040.

European nomenclature codes declared: C010402020101, C010402020199, P070402010301, P070402010302, C010401020101.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED1 658
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 GTIN1 658
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. Concept Medical B.V. was not found in either the U.S. or the Canadian register.

Other manufacturers in Netherlands

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