EU → North America Device Access

Neolook Solutions

NL-MF-000028851 · Netherlands · Utrecht

Neolook Solutions is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa5

Most frequent device types declared: 2.0, Neolook One, S2S Professional 2.0.

Among these devices, 4 are declared active.

Devices declared under this manufacturer

Catalogue references include CMP-PRD-501, ONE-PRD-401, PRO-DIG-100, S2SFam.

European nomenclature codes declared: V80, V0299.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED5
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 GTIN5
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. Neolook Solutions was not found in either the U.S. or the Canadian register.

Other manufacturers in Netherlands

All Netherlands manufacturers →