EU → North America Device Access

Nimmu Scandinavia AB

SE-MF-000046948 · Sweden · Norrtälje

Nimmu Scandinavia AB is registered in the European database on medical devices as a manufacturer, with 11 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa11

Devices declared under this manufacturer

Catalogue references include NA2-M, NA2-S, NI3-L, NI3-R, NI3-S, NR1-L.

European nomenclature codes declared: Y061299.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED11
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 GTIN11
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. Nimmu Scandinavia AB was not found in either the U.S. or the Canadian register.

Other manufacturers in Sweden

All Sweden manufacturers →