EU → North America Device Access

Nimacare AB

SE-MF-000050989 · Sweden · Djursholm

Nimacare AB is registered in the European database on medical devices as a manufacturer, with 1 677 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa1 677

Most frequent device types declared: Elevation cushion chair model with fastening straps, Nima 600 MESH INK, Nima 600 Skikt, Nima 600 Skikt Mesh INK, Nima 600 Skikt Tät.

Devices declared under this manufacturer

Showing 12 of 1 677 declared devices.

Catalogue references include 600SKIKTMESHINK3530, 600ST4242, DKH393610, KV5045, NB4242, NB4245.

European nomenclature codes declared: V08030102, V080399.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED1 677
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 GTIN1 677
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. Nimacare AB was not found in either the U.S. or the Canadian register.

Other manufacturers in Sweden

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