EU → North America Device Access

Mediroyal Nordic AB

SE-MF-000007821 · Sweden · Sollentuna

Mediroyal Nordic AB is registered in the European database on medical devices as a manufacturer, with 2 066 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa2 066

Most frequent device types declared: CRX621, MR1102, MR2220, MR2333, MR2352.

Devices declared under this manufacturer

Showing 12 of 2 066 declared devices.

Catalogue references include CRX621-XXL, MR01102000609, MR02333100609, MR02352200609, MR04921000809, MR2702-L.

European nomenclature codes declared: Y060606, Y061209, Y060603, Y060680, Y060613, Y06120601.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED2 066
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 GTIN2 066
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. Mediroyal Nordic AB was not found in either the U.S. or the Canadian register.

Other manufacturers in Sweden

All Sweden manufacturers →