EU → North America Device Access

Neko Health AB

SE-MF-000045605 · Sweden · Danderyd

Neko Health AB is registered in the European database on medical devices as a manufacturer, with 9 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa9

Most frequent device types declared: NekoLens.

Among these devices, 9 are declared active.

Devices declared under this manufacturer

Catalogue references include 100515, 101630, 101718, 101725, 102040, 102556.

European nomenclature codes declared: Z12040102, Z12040118, C99, Z12040180.

United States market access

FDA establishment registerRegistered with FDA
Matched entryNEKO HEALTH AB (SE) · FDA 3042165671
Devices in EUDAMED9
Country of registrationSweden

Device-level evidence

Devices with a numeric GTIN9
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: United States only. Neko Health AB is registered in the United States but was not found in the Canadian register.

Other manufacturers in Sweden

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