EU → North America Device Access

Hikemeister B.V.

NL-MF-000057279 · Netherlands · Nijmegen

Hikemeister B.V. is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa8

Most frequent device types declared: MH04005L, MH04006L, MH04011L, MH04014L, MH04115L.

Devices declared under this manufacturer

Catalogue references include MH04005L, MH04006L, MH04011L, MH04014L, MH04015L, VX021.

European nomenclature codes declared: Y091203, Y181803, M9001.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED8
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 GTIN8
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. Hikemeister B.V. was not found in either the U.S. or the Canadian register.

Other manufacturers in Netherlands

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