EU → North America Device Access

Customized innovations i Sverige AB

SE-MF-000047918 · Sweden · Stocksund

Customized innovations i Sverige AB is registered in the European database on medical devices as a manufacturer, with 68 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa68

Most frequent device types declared: Customized Ankle Support, Customized Back Support, Customized Elbow Support Series, Customized Knee support series, Customized Wrist Support Series.

Devices declared under this manufacturer

Showing 12 of 68 declared devices.

Catalogue references include CCS2113S, CCS2140S, CCS2150BLL, CCS2182M, CCS4028S, CCS5047M.

European nomenclature codes declared: Y061209, Y060308, Y060615, Y06120601, Y060609.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED68
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 GTIN68
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. Customized innovations i Sverige AB was not found in either the U.S. or the Canadian register.

Other manufacturers in Sweden

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