EU → North America Device Access

KipKep

NL-MF-000006071 · Netherlands · Eindhoven

KipKep is registered in the European database on medical devices as a manufacturer, with 14 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa14

Most frequent device types declared: Lexie Heating Pillow, Woller.

Devices declared under this manufacturer

Showing 12 of 14 declared devices.

Catalogue references include 2792, 3553, 3720, 4390, 4659, 4857.

European nomenclature codes declared: V9099.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED14
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 GTIN14
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. KipKep was not found in either the U.S. or the Canadian register.

Other manufacturers in Netherlands

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