EU → North America Device Access

Trionic Sverige AB

SE-MF-000014178 · Sweden · Uppsala

Trionic Sverige AB is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa8

Devices declared under this manufacturer

Catalogue references include 11-00-202, 22-00-000, 23-00-000, 24-00-000, 25-00-000, MANY.

European nomenclature codes declared: Y120606.

United States market access

FDA establishment registerRegistered with FDA
Matched entryTRIONIC SVERIGE AB (SE) · FDA 3007905163
Devices in EUDAMED8
Country of registrationSweden

Device-level evidence

Devices with a numeric GTIN8
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: United States only. Trionic Sverige AB is registered in the United States but was not found in the Canadian register.

Other manufacturers in Sweden

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