EU → North America Device Access

Nord Ability AB

SE-MF-000002255 · Sweden · Smögen

Nord Ability AB is registered in the European database on medical devices as a manufacturer, with 64 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa64

Most frequent device types declared: NORD LINER TF CUSHION, NORD LINER TT CUSHION, NORD SLEEVE, NORD TF BRIM.

Devices declared under this manufacturer

Showing 12 of 64 declared devices.

Catalogue references include 111203, 212216, 212218, 212226, 221202, 222204.

European nomenclature codes declared: Y062409, Y062415.

United States market access

FDA establishment registerRegistered with FDA
Matched entryNORD ABILITY AB (SE) · FDA 3029727446
Devices in EUDAMED64
Country of registrationSweden

Device-level evidence

Devices with a numeric GTIN64
Found in the U.S. device database34
Share53.1 %

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. Nord Ability AB is registered in the United States but was not found in the Canadian register.

Other manufacturers in Sweden

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