EU → North America Device Access

Nil Medical AB

SE-MF-000051068 · Sweden · Umeå

Nil Medical AB is registered in the European database on medical devices as a manufacturer, with 25 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa25

Catalogue references include N1001-134, N1001-80, N1001-86, N1001-W-M/L, N2001, N2003.

European nomenclature codes declared: V9099.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED25
Country of registrationSweden

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN25
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. Nil Medical AB was not found in either the U.S. or the Canadian register.

Other manufacturers in Sweden

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