EU → North America Device Access

Wake Up International B.V.

NL-MF-000023964 · Netherlands · Zeist

Wake Up International B.V. is registered in the European database on medical devices as a manufacturer, with 17 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa17

Most frequent device types declared: Dryboxen, Wake Up Drying Tablets.

Among these devices, 2 are declared active.

Devices declared under this manufacturer

Showing 12 of 17 declared devices.

Catalogue references include 409007067, 409007069, 409007070, 409007071, 409007109, 409007780.

European nomenclature codes declared: D0899, D99.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED17
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 GTIN17
Found in the U.S. device database1
Share5.9 %
⚠ The two levels disagree here. This company’s name was not found in the FDA establishment register, yet some of its devices are in the U.S. device database. The likeliest reading is that the name match failed.

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. Wake Up International B.V. was not found in either the U.S. or the Canadian register.

Other manufacturers in Netherlands

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